Leica Biosystems Nussloch SPECTRAST Multistainer User Manual

Leica Biosystems Nussloch GmbH Multistainer

User Manual

Instructions for UseLeica HistoCore SPECTRA STStaining machineLeica HistoCore SPECTRA ST V 0.5 RevC, English 08 /2014Order No.: 14 0512 80100 RevCAlways keep this manual with the instrument.Read carefully before working with the instrument.V 0.5 RevC - 08/2014DRAFT2014-08-21
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1Leica HistoCore SPECTRA STThe information, numerical data, notes and value judgments contained in this manual represent the current state of scientific knowledge and state-of-the-art technology as we understand it following thorough investigation in this field. We are under no obligation to update the pres-ent Instructions for Use periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional copies, updates etc. of these Instruc-tions for Use.To the extent permitted in accordance with the national legal system as applicable in each indi-vidual case, we shall not be held liable for errone-ous statements, drawings, technical illustrations etc. contained in these Instructions for Use. In particular, no liability whatsoever is accepted for any financial loss or other consequential damage caused by or related to compliance with state-ments or other information in these instructions for use.Statements, drawings, illustrations and other information regarding the contents or technical details of the present Instructions for Use are not to be considered warranted characteristics of our products. These are determined only by the contract provisions agreed between ourselves and our customers.Leica reserves the right to change technical spec-ifications as well as manufacturing processes without prior notice. Only in this way is it pos-sible to continuously improve the technology and manufacturing techniques used in our products.This document is protected under copyright laws. All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH.Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy, microfiche, web cam or other methods – includ-ing any electronic systems and media – requires express prior permission in writing by Leica Bio-systems Nussloch GmbH.For the instrument serial number and year of manufacture, please refer to the nameplate on the back of the instrument.© Leica Biosystems Nussloch GmbHNOTELeica Biosystems Nussloch GmbHHeidelberger Str. 17 - 19D-69226 NusslochGermanyPhone: +49 6224 143-0Fax: +49 6224 143-268 Internet: http://www.LeicaBiosystems.comDRAFTDRAFTDRAFTNOTENOTE2014-08-21ppentific knowledge and state-of-entific knowledge and stay as we understand it following as we understand it followingation in this field.ation in this fggggdetails of the present Instdetails of the present Instto be considered warrano be considered warranour products. These areour products. These are
2Instructions for Use V 0.5 RevC - 08/2014Table of Contents1. Important Information ................................................................................................................. 51.1 Instrument Name .......................................................................................................................... 51.2 Symbols and their meanings....................................................................................................... 51.3 Instrument type ........................................................................................................................... 131.4 Qualification of personnel ......................................................................................................... 131.5 Intended use of instrument ....................................................................................................... 132. Safety ......................................................................................................................................... 142.1 Safety notes ................................................................................................................................. 142.2 Warnings ...................................................................................................................................... 162.3 Safety features on the instrument ........................................................................................... 203. Instrument Components and Specifications ......................................................................... 213.1 Standard delivery—packing list............................................................................................... 213.2 Technical Data ............................................................................................................................ 223.3 Overview ...................................................................................................................................... 244. Installation and Starting Up ..................................................................................................... 274.1 Installation site requirements ................................................................................................... 274.2 Running water connection ........................................................................................................ 284.2.1 Joint connection of all 6 rinsing water stations .................................................................... 294.2.2 Combined connection 4+2 rinsing water stations ................................................................. 304.2.3 Wastewater connection ............................................................................................................ 314.3 Electrical Connection ................................................................................................................. 324.3.1 Using an external uninterruptible power supply (UPS) ........................................................ 334.4 Exhaust air connection .............................................................................................................. 334.5 Switching the instrument on and off ....................................................................................... 345. Operation ..................................................................................................................................... 355.1 User interface – overview ......................................................................................................... 355.2 Status bar elements ................................................................................................................... 365.3 Process status display ............................................................................................................... 375.4 Displaying the drawers .............................................................................................................. 395.5 Main menu-overview ................................................................................................................. 405.5.1 The keyboard ............................................................................................................................... 415.6 User settings ................................................................................................................................ 435.7 Basic settings .............................................................................................................................. 455.7.1 Language settings ...................................................................................................................... 465.7.2 Country-specific settings .......................................................................................................... 465.7.3 Date and time .............................................................................................................................. 47DRAFTDRAFT2014-08-21ent Nament Name.................................................................................................................................................................................. and their meaningsand their meanin..........................................................................................................................................ent typent type........................................................................................................................................................................................ation of personnelation of personnel
3Leica HistoCore SPECTRA STTable of Contents5.7.4 Alarm and signal tones .............................................................................................................. 475.7.5 Setting the oven .......................................................................................................................... 495.7.6 Movement speed - up/down movement (agitation) .............................................................. 505.7.7 Data management ...................................................................................................................... 515.7.8 Service access ............................................................................................................................ 545.7.9 Event view .................................................................................................................................... 545.7.10 Network settings ......................................................................................................................... 555.8 Reagent list .................................................................................................................................. 565.8.1 Define heated reagent (optional) ............................................................................................. 575.8.2 Creating a new reagent ............................................................................................................. 585.8.3 Process classes .......................................................................................................................... 605.9 Staining program ........................................................................................................................ 635.9.1 Staining program - general settings ........................................................................................ 645.9.2 Leica staining programs (preinstalled) ...................................................................................655.9.3 Adapting the Leica H&E staining program ............................................................................. 665.9.4 User-defined staining programs ............................................................................................. 665.9.5 Creating a new staining program............................................................................................. 675.9.6 Inserting a new program step (continued) ............................................................................. 695.9.7 Resorting a program step .......................................................................................................... 705.9.8 Prioritizing programs .................................................................................................................. 715.9.9 Creating a bathlayout ................................................................................................................. 725.9.10 Adjusting a bathlayout ............................................................................................................... 756. Daily Instrument Setup ........................................................................................................... 786.1 Preparing the instrument for daily setup ................................................................................ 786.2. Daily setup of the instrument .................................................................................................... 796.2.1 Preparation and handling of reagent cuvettes ...................................................................... 796.2.2 Automatic fill level scan ............................................................................................................ 816.3 Reagent management system (RMS) ...................................................................................... 826.4 Station features ........................................................................................................................... 846.5 Prepare slide rack ...................................................................................................................... 896.6 The staining process .................................................................................................................. 916.6.1 Start the staining process ......................................................................................................... 916.7.2 Monitoring the staining process .............................................................................................. 936.7.3 Staining process completed ..................................................................................................... 946.7.4 Canceling the staining program ............................................................................................... 956.7.5 Operation as a workstation ....................................................................................................... 96DRAFTDRAFTDRAFT2014-08-21ng the oveng the oven.................................................................................................................................................................ement speed - up/down movement (agitation)ement speed - up/down movement (agitatio.....................................managementmanagemen.............................................................................................................................................................ce accessce access
4Instructions for Use V 0.5 RevC - 08/20147. Cleaning and Maintenance ....................................................................................................987.1 Important notes about this instrument cleaning ................................................................... 987.1.1 Exterior surfaces, varnished surfaces, instrument cover.................................................... 987.1.2 TFT touchscreen ......................................................................................................................... 987.1.3 Interior and drain pan ................................................................................................................ 997.1.4 Transport arms ............................................................................................................................ 997.1.5 Reading module for specimen slides ...................................................................................... 997.1.6 Input and output drawers ........................................................................................................ 1007.1.7 Dry transfer station ................................................................................................................... 1007.1.8 Transfer station (optional) ....................................................................................................... 1007.1.9 Reagent cuvettes, rinsing water cuvettes and heated cuvettes (optional) .................... 1017.1.10 Rack and clip ............................................................................................................................. 1027.1.11 Water drain ................................................................................................................................ 1037.1.12 Water drain hose ...................................................................................................................... 1047.1.13 Water intake filter – changing the filter cartridge .............................................................. 1047.1.14 Replacing the active carbon filter.......................................................................................... 1057.1.15 Cleaning the ovens ................................................................................................................... 1067.1.16 Oven air filter ............................................................................................................................. 1077.2 Recommended maintenance and cleaning intervals ......................................................... 1088. Malfunctions and Troubleshooting ...................................................................................... 1118.1 Fault remedies for instrument malfunctions ........................................................................ 1118.2 Power failure scenario ............................................................................................................ 1148.3 Replace main fuses .................................................................................................................. 1159. Instrument Components and Specifications ..................................................................... 1169.1 Optional instrument components ........................................................................................... 1169.2 Optional Accessories ............................................................................................................... 11810. Garantie und Service ............................................................................................................ 12411. Decommissioning and Disposal ......................................................................................... 12512. Decontamination Certificate (master) ............................................................................... 126Appendix 1 ......................................................................................................................................... 128A1 Compatible reagents ................................................................................................................ 128Table of ContentsDRAFTDRAFTDRAFT2014-08-21nt notes about this instrument cleaningt notes about this instrument cleani........................................................................surfaces, varnished surfaces, instrument coversurfaces, varnished surfaces, instrument c.................................chscreenhscreen................................................................................................................................................................................and drain panand drain pa
5Leica HistoCore SPECTRA ST1. Important Information1.2 Symbols and their meaningsLeica Biosystems GmbH assumes no liability for consequential loss or damage due to failure to observe the following notes, particularly in relation to transportation and package handling, and failure to observe the notes for handling the instrument carefully.Symbol: Title of the symbol: CautionDescription: Indicates the need for the user to consult the instruc-tions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.Symbol: Title of the symbol: NotesDescription: This symbol indicates important information for the user. The notes appear in a gray and are marked by this symbol.Symbol: Title of the symbol: Item numbersDescription: Numbers and parentheses refer to item numbers in the illustrations.Symbol: Title of the symbol: Function keysDescription: Function keys that must be pushed on the touch-screen or activated in the software are shown in BOLD.Symbol: Title of the symbol: Leica Biosystems GmbH company logoDescription: Indicates the trademark of the company.1.1 Instrument NameThe full name of the device is HistoCore SPECTRA ST. The device is called SPECTRA ST to en-sure that the Instructions for Use are well legible. DRAFTDRAFTDRAFT2014-08-21name of the device is HistoCore SPECTRA ST. The device is cahe Instructions for Use are well legible. 2014-08-21
6Instructions for Use V 0.5 RevC - 08/20141. Important Information1.2 Symbols and their meanings (continued)Symbol: Title of the symbol: Warning, hot surfaceDescription: Instrument surfaces which become hot during opera-tion are marked with this symbol. Avoid direct contact to prevent risk of burning.Symbol: Title of the symbol: ManufacturerDescription: Indicates the medical device manufacturer, as de-fined in EU Directives. Symbol: Title of the symbol: Date of ManufactureDescription: Indicates the date when the medical device was manufactured. Symbol: Title of the symbol: CE ComplianceDescription: The CE marking is the manufacturer's declaration that the medical product meets the requirements of the applicable EC directives.Symbol: Title of the symbol: In vitro diagnostic medical deviceDescription: Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.Symbol: Title of the symbol: China ROHSDescription: Environmental protection symbol of the China RoHS directive. The number in the symbol indicates the "Environment-friendly Use Period" of the product in years. The symbol is used if a substance restricted in China is used in excess of the maximum permit-ted limit.DRAFTDRAFTDRAFT2014-08-21Title of the symbol:tle of the symbWarning, hot surfaceWarning, hot surfaceDescription:DescriptionInstrument surfaces which becomument surfaces which becom
7Leica HistoCore SPECTRA ST1. Important Information1.2 Symbols and their meanings (continued)Symbol: Title of the symbol: WEEE SymbolDescription: The WEEE symbol, indicating separate collection for WEEE - Waste of electrical and electronic equip-ment, consists of the crossed-out wheeled bin (§ 7 ElektroG).Symbol: Title of the symbol: Alternating currentDescription:Symbol: Title of the symbol: PE terminalDescription:Symbol: Title of the symbol: Earth (Ground) terminalDescription:Symbol: Title of the symbol: Article numberDescription: Indicates the manufacturer's catalogue number so that the medical device can be identified.Symbol: Title of the symbol: Serial NumberDescription: Indicates the manufacturer's serial number so that a specific medical device can be identified.Symbol: Title of the symbol: Consult instructions for useDescription: Indicates the need for the user to consult the instruc-tions for use.DRAFTDRAFT2014-08-21Title of the symbol:Title of the symbol:WEEE SymbolWEEE SymboDescription:DescriptThe WEEE symbol, indicating he WEEE symbol, indicating s
8Instructions for Use V 0.5 RevC - 08/20141. Important Information1.2 Symbols and their meanings (continued)Symbol: Title of the symbol: ON (Power)Description: The power supply is connected upon pushing the power switch.Symbol: Title of the symbol: OFF (Power)Description: The power supply is disconnected upon pushing the power switch.Symbol: Title of the symbol: Caution, possibility of electronic shockDescription Instrument surfaces or areas which become ener-gized during operation are marked with this symbol. Therefore, direct contact is to be avoided.Symbol: Title of the symbol: Caution: danger of crushingSymbol: Title of the symbol: IPPC symbolDescription: The IPPC symbol includes IPPC symbol Country code to ISO 3166, e.g. DE for Germany Regional identifier, e.g. HE for Hesse Registration number, unique number beginning with 49. Treatment method, e.g. HT (heat treatment)Symbol: Title of the symbol: Fragile, handle with careDescription: Indicates a medical device that can be broken or damaged if not handled carefully.DRAFTDRAFTDRAFT2014-08-21Title of the symbol:tle of the symbON (Power)(Power)Description:DescriptionThe power supply is connectedpower supply is connected
9Leica HistoCore SPECTRA ST1. Important Information1.2 Symbols and their meanings (continued)Symbol: Title of the symbol: Keep dryDescription: Indicates a medical device that needs to be protected from moisture.Symbol: Title of the symbol: Do not stackDescription: Stacking of the transport package is not allowed and no load should be placed on the transport package.Symbol: Title of the symbol: This way upDescription: Indicates correct upright position of the transport package.Symbol: Title of the symbol: Temperature limit for transportDescription: Indicates the temperature limits for transport to which the medical device can be safely exposed.Symbol: Title of the symbol: Temperature limit for storageDescription: Indicates the temperature limits for storage to which the medical device can be safely exposed.DRAFTDRAFTDRAFT2014-08-21Title of the symbol:Title of the symbol:Keep dryKeep dryDescription:DescriptIndicates a medical device thandicates a medical device tha
10 Instructions for Use V 0.5 RevC - 08/20141. Important Information1.2 Symbols and their meanings (continued)When delivering the instrument, the recipient must check that the ShockWatch impact indicator and tilt indicator are intact. The responsible Leica representative must be no-tified in the case that one or all indicators have been triggered. Symbol: Title of the symbol: Humidity limitation for transport and storageDescription: Indicates the range of humidity for transport and storage to which the medical device can be safely exposed.Appearance: Indication: ShockWatch Impact Indicator - Red - 50GFunctional description In the Shockwatch system, a precision glass tube shows shocks or impacts that are above a specified intensity through red coloration. Exceeding a defined acceleration (g value) destroys the surface tension of the liquid in the interior of the tube. This causes the indicator tube to change color.Appearance: Indication: Tilt indicatorFunctional description Indicator to monitor whether the shipment has been transported and stored in upright position according to your requirements. With a pitch of 60° or more, the blue quartz sand flows into the arrow-shaped indica-tor window and sticks there permanently. Improper handling of the shipment is immediately detectable and can be proven definitively.DRAFTDRAFTDRAFT2014-08-21Title of the symbol:tle of the symbHumidity limitation for transport Humidity limitation for transport Description:DescriptionIndicates the range of humiditycates the range of humidity
11Leica HistoCore SPECTRA ST1. Important Information1.2 Symbols and their meanings (continued)US/Canada only:This device complies with Part 15 of the FCC Rules and with Industry Canada licence-exempt RSS standard(s).Operation is subject to the following two conditions:(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes:(1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonc-tionnement.This equipment has been tested and found to comply with the limits for a Class B digital device, pursu-ant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help.Changes or modifications made to this equipment not expressly approved by Leica Biosystems Nussloch GmbH may void the FCC authorization to operate this equipment. FCC ID: 2AAPD-SPECTRASTIC: 12028A-SPECTRASTDRAFTDRAFTDRAFT2014-08-21This device complies with Part 15 of the FCC Rules anThis device complies with Part 15 of the FCC Rules an
12 Instructions for Use V 0.5 RevC - 08/20141. Important InformationJapan only:Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese Telecommunications Business Law (電気通信事業法) This device should not be modified (otherwise the granted designation number will become invalid) CSA Statement (Canada/USA)The CSA test mark means that a product has been tested and fulfills the applicable safety standards:CAN/CSA-C22.2 No. 61010-1-04; CAN/CSA-C22.2 No. 61010-2-010-04; CAN/CSA-C22.2 No. 61010-2-101-04 Product is listed under Master Contract Number: 2173331.2 Symbols and their meanings (continued)DRAFTDRAFTDRAFT2014-08-21Japanese Radio Law and Japanese Tenese Radio Law and Japanese Te
13Leica HistoCore SPECTRA ST1. Important Information1.4 Qualification of personnel1.5 Intended use of instrumentAny use of the instrument that deviates from the designated use is considered improper. Failure to adhere to these instructions may result in an accident, personal injury, dam-age to the instrument or accessory equipment. Proper and intended use includes com-pliance with all inspection and maintenance instructions, along with the observance of all instructions in the Instructions for Use as well as the constant inspection of the reagents for storage life and quality. The HistoCore SPECTRA ST carries out the speci-fied staining steps automatically. Thus, the manufacturer assumes no liability for the staining results in the case that the staining steps and programs are entered incorrectly. Thus, the end user is independently responsible for self-created reagents or program entries.All information provided in these Instruc-tions for Use applies only to the instru-ment type indicated on the title page. A nameplate indicating the instrument se-rial number is attached at the left side of the instrument. The accompanying Fig. 1 is provided as an example only and shows a valid nameplate for this instrument.Fig. 1The exact data of the different in-strument versions are specified in Chap. 3.2.1.3 Instrument type The Leica HistoCore SPECTRA ST must only be operated by authorized personnel compre-hensively trained in using lab reagents and their application in histology. All laboratory personnel designated to operate this instrument must read these Instructions for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.The Leica HistoCore SPECTRA ST is a staining machine for laboratory applications. It is in-tended for the preparation of histological and cytological tissue samples.The Leica HistoCore SPECTRA ST is also suitable for IVD (in vitro diagnostics).DRAFTDRAFTDRAFT2014-08-21tion provided in these Instrucion provided in these Ins-se applies only to the instrue applies only to the instru--ndicated on the title page Andicated on the title pa08-21
14 Instructions for Use V 0.5 RevC - 08/2014These Instructions for Use include important instructions and information related to the oper-ating safety and maintenance of the instrument.The Instructions for Use are an important part of the product, and must be read carefully prior to startup and use and must always be kept near the instrument.2. Safety2.1 Safety notes The safety and caution notes in this chapter must be observed at all times. Be sure to read these notes even if you are already familiar with the operation and use of other Leica products. The protective devices located on the instrument and the accessories must not be re-moved or modified. Only qualified service personnel authorized by Leica may repair the instrument and access its internal components.Residual risks The instrument has been designed and constructed with the latest state-of-the-art technology and according to recognized standards and regulations with regard to safety technology. Operating or handling the instrument incorrectly can place the user or other personnel at risk of injury or can cause damage to the instrument or property.  The instrument may be used only as intended and only if all of its safety features are in proper working condition.  If malfunctions are to occur that can impede safety, the instrument must be put out of operation immediately and the responsible Leica service technician must be notified. Only original spare parts and permitted original Leica accessories may be used.These Instructions for Use must be appropriately supplemented as required by the exist-ing regulations on accident prevention and environmental safety in the operator‘s coun-try.The instrument's CE certificate can be found on the Internet at: http://www.leicabiosystems.comDRAFTDRAFT2014 08 21safety and caution notes in this chapter must be observed at ad these notes even if you are already familiar with the operateica prod cts2014 08 21
15Leica HistoCore SPECTRA ST2. Safety2.1 Safety notes (continued)This instrument has been built and tested in accordance with the safety requirements for elec-trical equipment for measurement, control, and laboratory use. To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these In-structions for Use.  You must make sure that any data loaded onto the instrument is free of viruses. No anti-virus software is provided. The instrument is only suited for integration in a firewall-protected network. Leica shall not assume any liability for errors due to integration in an unprotected network. ONLY technicians trained and permitted by Leica can connect a USB input device (mouse/keyboard, etc.). This also applies to the network connection, which is to be used only together with RemoteCare (service diagnostics) and/or a LIS connection.In the interest of specimen safety, the SPECTRA ST indicates when it is necessary for the user to interfere using text messages and audible signals. Therefore, the SPECTRA ST staining machine requires that the user is within hearing distance during operation.The product uses a class 1 laser source.Caution, laser radiation! Do not look into the beam! This can cause injury to the con-junctiva.LASER RADIATION - DO NOTSTARE INTO BEAM EN 60825-1: 2007P<1 mW, O= 630 to 670 nmPulse duration = 500 μsClass 1 laser productDRAFTDRAFTDRAFT2014-08-21ment has been built and tested in accordance with the safetyment has been built and tested in accordance with the safetyment for measurement, control, and laboratory use. To mainment for measurement, control, and laboratory use. To maine operation the user must observe all notes and warningse operation the user must observe all notes and warnings
16 Instructions for Use V 0.5 RevC - 08/20142. Safety2.2 WarningsWarnings on the instrumentThe safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention. Operating the instrument safely is, above all, the responsibility of the owner, as well as the designated personnel who operate, service or repair the instrument.To ensure trouble-free operation of the instrument, make sure to comply with the following instructions and warnings.Please note that electrostatic discharges can result due to direct or indirect contact with the SPECTRA ST.Certain surfaces of the instrument are hot during operation under normal conditions. They are marked with this warning sign. Touching these surfaces without suitable safe-ty measures can cause burns.Markings on the instrument surface showing the warning triangle indicate that the cor-rect operating instructions (as defined in these Instructions for Use) must be followed when operating or replacing the item marked. Failure to adhere to these instructions may lead to accidents causing personal injury and/or damage to the instrument or ac-cessories or destroyed, unusable specimens.Safety notes on the instrument itself, which are marked with a round prohibitory sign, indicate that the situation described by the symbol must be avoided and the correct op-erating instructions (as defined in these Instructions for Use) must be followed when operating the instrument marked. Failure to adhere to these instructions may lead to ac-cidents causing personal injury and/or damage to the instrument or accessories or de-stroyed, unusable specimens.DRAFTDRAFTDRAFT2014-08-21strumentstrumeni i t ll d i thi i t t b th f t li i t ll d i thi i t t b th f t l
17Leica HistoCore SPECTRA ST2. SafetyWarnings – Handling reagentsWarnings - Transport and installation Take care when handling solvents! Always wear protective clothing suitable for laboratory use, as well as rubber gloves and safety goggles when handling the chemicals used in this instrument.  The installation site must be well-ventilated. Alternatively, the instrument can be connected to an external exhaust air extraction system. The chemicals to be used in the SPECTRA ST can be easily flammable and hazardous to health. Do not operate the instrument in rooms with an explosion hazard. When disposing of spent reagents, observe the applicable local regulations and the waste disposal regulations of the company/institution in which the instrument is be-ing operated. Reagent cuvettes must always be filled outside of the instrument in compliance with the safety information.2.2 Warnings (continued) The instrument must only be transported in an upright position. The empty weight of the instrument is 185 kg; therefore, four qualified persons are re-quired to lift or carry the instrument!  Use non-skid gloves to lift the device! Leica recommends commissioning a transport company to transport, install or (where applicable) relocate the instrument. Place the instrument on a sturdy laboratory bench and adjust it to a horizontal posi-tion. Prevent the instrument from being exposed to direct sunlight!  Only connect the instrument to a grounded power socket. Do not interfere with the grounding function by using an extension cord without a ground wire. Exposure to extreme temperature changes between storage and installation locations and high air humidity may cause condensation inside the instrument. If this is the case, wait at least two hours before switching on the instrument. The instrument must only be installed at the area of use with and under direction of Leica-trained staff. This also applies to the potential transport to a new area of use. We recommend using personnel trained by Leica to recommission the instrument.DRAFTDRAFTDRAFT2014-08-21sport and installationsport and installationlb di2014 08 21
18 Instructions for Use V 0.5 RevC - 08/20142. SafetyWarnings – Operating the instrument The instrument may be operated by trained laboratory personnel only. It must only be operated for the purpose of its designated use and according to the instructions con-tained in these Instructions for Use. Antistatic protective clothing made from natural fibers (e.g. cotton) should be worn when working with the instrument. In the event of an emergency, switch off the power switch and unplug the instrument from the power supply (circuit breaker in accordance with EN ISO 61010-1). There is a fire hazard if work with an exposed flame (e.g. Bunsen burner) is carried out in the direct vicinity of the instrument (solvent vapors). Therefore, keep all ignition sources at least 2 meters away from the instrument! Be absolutely certain to operate the instrument either with the active carbon filter, technical ventilation system and an exhaust hose, as even when the instrument is used according to its designated use, solvents arise that are both hazardous to health and inflammable!  For the instrument fume control, Leica recommends a delivery volume of 50 m3/h and an air exchange rate of 8 (25 m3/m2h) in the lab.  Opening the hood when one or more staining program(s) are active causes delays in the respective processing steps since no transport movements take place for this time frame. This can result in changes to the staining quality. Make sure to keep the hood closed if the staining programs are active. Leica assumes no liability for loss of quality for staining programs caused by opening the hood dur-ing the staining process. CAUTION when closing the hood: Crushing hazard! Do not reach into the swivel range of the hood!2.2 Warnings (continued)DRAFTDRAFTDRAFT2014-08-21ing the instrumentng the instrume2014 08 21
19Leica HistoCore SPECTRA ST2. Safety2.2 Warnings (continued) Before any maintenance, switch off the instrument and unplug it from power supply. When using cleaners, please comply with the safety instructions of the manufacturer and the laboratory safety regulations. The plastic reagent cuvettes of the rinsing water and reagent stations can be cleaned in a dishwasher at a maximum temperature of +65 °C. Any standard cleaning agent for laboratory dishwashers may be used. Never clean the plastic reagent cuvettes at higher temperatures since it can cause the reagent cuvettes to become deformed! Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol, detergents containing alcohol (glass cleaners), abrasive cleaning powders, solvents containing acetone, ammonia, chlorine, or xylene!  Wear suitable protective clothing when cleaning the instrument (lab coat and gloves). Clean the hoods and housing using mild commercial, pH-neutral household cleaners. The finished surfaces are not resistant to solvents and xylene substitute!Warnings – Maintenance and cleaningWarnings – Operating the instrument (continued) No liquid may reach behind covers and in columns when working and cleaning. This also applies for transport arms. CAUTION for programs that start with an oven step! In this case, the load station from which the specimen slide is removed with the transport arm must NOT be filled with a flammable reagent (e.g. xylene, xylene substitute or alcohols). The oven tempera-ture can be up to 70 °C. This can result in the reagent igniting and can cause damage to the instrument and specimens. CAUTION when filling the heated reagent cuvettes. Flammable reagents (e.g. xylene, xylene substitute or alcohols) must not be added to the heated reagent cuvettes.DRAFTDRAFT2014-08-21rating the instrument rating the instrument (continued)(continued)2014 08 21
20 Instructions for Use V 0.5 RevC - 08/20142. Safety2.3 Safety features on the instrumentAs soon as the hood of the instrument is opened, the movements of the transport arms are stopped in a horizontal plane (x and y-axis) for safety reasons to eliminate specimen damage due to collision with moving parts. Make sure to keep the hood closed if the staining programs are active. Leica assumes no liability for loss of quality for staining programs caused by opening the hood dur-ing the staining process.  Opening the hood when one or more staining program(s) is/are active causes delays in the respective processing steps since no transport movements take place for this time frame. This can result in changes to the staining quality.DRAFTDRAFTDRAFT2014-08-21e hood of the instrument is opened, the movements of thee hood of the instrument is opened, the movements of theorizontal plane (x and y-axis) for safety reasons to eliminaterizontal plane (x and y-axis) for safety reasons to eliminaten with moving parts.n with moving part
21Leica HistoCore SPECTRA ST3. Instrument Components and Specifications3.1 Standard delivery—packing listQty Designation Order No.1 SPECTRA ST basic instrument 14 0512 475671 Power cable country-specific46 Reagent cuvettes, assembly, including reagent cuvette cover 14 0512 470866 Water flow cuvettes, assembly 14 0512 470876 O-rings 7x2, for water flow cuvette connecting piece 14 0253 47088Sanitation and water supply equipment accessories:1Outlet hose, length: 2 m 14 0475 357472Inflow hoses, Ø 10 mm, length: 2.5 m 14 0474 323251 Pressure hose, 1.5 m extension 14 0512 493341 Y piece 14 3000 003512 Double nipple G3/4 G3/8 14 3000 003501 Water filter housing 14 0512 493311 Filter cartridge 14 0512 493321Bushing G 3/4 14 3000 003601 Exhaust hose, 2 m 14 0475 357622 Active carbon filter 14 0512 471313 Rack for 30 specimen slides (3 pcs. per package) 14 0512 524731 Clip for rack for 30 specimen slides (yellow, 3 pcs. per package) 14 0512 525761 Clip for rack for 30 specimen slides (dark blue, 3 pcs. per package) 14 0512 524781 Clip for rack for 30 specimen slides (red, 3 pcs. per package) 14 0512 524801 Clip for rack for 30 specimen slides (white, 3 pcs. per package) 14 0512 524841 Instructions for Use, printed (German/English, with Language CD 14 0512 80200)14 0512 80001DRAFTDRAFTDRAFT3.3. Instrument CompInstrument Com2014-08-21ationonA ST basic instrumentA ST basic instrum
22 Instructions for Use V 0.5 RevC - 08/20143. Instrument Components and Specifications3.2 Technical DataNominal supply voltages: 100-240 V AC +10 %Nominal frequency: 50/60 HzPower draw: 1350 VAFuses: 2 x T16 A H 250 V ACIEC 1010 classification: Protection class 1Pollution degree: 2Overvoltage category: IIFresh water connection:Hose material: PVCHose length: 2500 mmConnecting piece: G3/8Inner diameter: 10 mmOuter diameter: 16 mmInternal pressure: Minimum: 2 barMaximum: 6 barRequired flow rate: Min. 1,7 l/minuteRequired water quality: Type 1, ISO 3696Waste water connection:Hose length: 2000 mm/4000 mmInner diameter: 32 mmOuter diameter: 36.8 mmExhaust air:Hose length: 2000 mmInner diameter: 50 mmOuter diameter: 60 mmExhaust performance: 27.3 m3/hDRAFTDRAFTts and Specificationsts and Specificationp2014-08-21ages:es:8100-24000-240V AC V AC +10%50/600/60HzHz
23Leica HistoCore SPECTRA ST3. Instrument Components and SpecificationsExhaust extraction: Active carbon filter and exhaust hose for connect-ing with an external exhaust systemHeat emission: 1350 J/sA-weighted noise level: < 70 dB (A)International protection class: IP20Sockets 1 x RJ45 Ethernet (rear): RJ45 - LAN (external data management)1 x RJ45 Ethernet (front): Only for service purposes2 x USB 2.0: 5 V/500 mA (service & data storage)3.2 Technical data (continued)When using an external uninterruptible power supply (UPS), it should be designed for a capacity of at least 1350 VA and secure operation over a time frame of at least 10 min-utes.Ambient conditions:Operation:Temperature: +18 °C to +30 °CRelative humidity: 20 % to 80 %, non-condensingOperating elevation: Up to a max. of 2000 m above sea levelStorage:Temperature: +5 °C to +50 °CRelative humidity: 10 % to 85 %, non-condensingTransport:Temperature: -29 °C to +50 °CRelative humidity: 10 % to 85 %, non-condensingDimensions and weightDimensions (length x depth x height): Hood closed: 135.4 x 78.5 x 58.5 cmHood open: 135.4 x 78.5 x 94.3 cmEmpty weight (without reagents and accessories): 185 kgDRAFTDRAFTDRAFT3.3. Instrument CompInstrument Com2014-08-21on: Active carbon filter and exhctive carbon filter and exhing with an external exhauing with an external exhau
24 Instructions for Use V 0.5 RevC - 08/20143. Instrument Components and Specifications3.3 OverviewFig. 2Front view1234561Insert for active carbon filter 6Screen with user interface2Read-in area for Leica reagents 7a USB sockets (2 pcs.),3Input drawer 7b Service access4Output drawer 8ON/OFF switch5Screen holder with interior lighting 9Lid7a/b89The service access (7b, Fig. 2) may only be used by service technicians certified by Leica!The cover of the read-in area (2, Fig. 2) may only be removed by a service technician certified by Leica.DRAFTDRAFTDRAFTts and Specificationsts and Specificationp2014-08-212014 08 212014 08 21
25Leica HistoCore SPECTRA ST3. Instrument Components and SpecificationsFig. 3Rear view3.3 Overview(continued)1Network connection (RemoteCare/LIS)2Power supply3Waste outlet4Running water connections5Exhaust air connection12345DRAFTDRAFTDRAFT3.3. Instrument CompInstrument Com2014-08-212014 08 21
26 Instructions for Use V 0.5 RevC - 08/20143. Instrument Components and Specifications3.3 Overview(continued)Inside viewFig. 41Left transport arm 6Transfer station for SPECTRA CV (optional)2Specimen slide reader module 7Right transport arm3Load station, 5 pcs. 8Rinsing water stations, 6 pcs.4Dry transfer stations, 2 pcs. 9Heated reagent stations, 4 pcs. (optional)5Unload station, 5 pcs. 10 Drying oven stations, 6 pcs12345678910DRAFTDRAFTDRAFTts and Specificationsts and Specificationp2014-08-212014 08 21
27Leica HistoCore SPECTRA ST It must be ensured that there is a mostly vibration-free floor and sufficient clear space (ap-prox. 1.10 cm) above the laboratory bench to allow unobstructed opening of the lid. Condensation water may form in the instrument if there is an extreme difference in tempera-ture between the storage location and the installation site and if air humidity is high at the same time. A waiting time of at least two hours must be observed each time before switching on. Failure to comply with this may cause damage to the instrument. Stable, exactly horizontal and level laboratory bench at least 1.40 m wide and 0.80 m deep. The counter area must be designed for handling loads of at least 150 kg/m2, vibration-free and level.  Fume hood at a max. 2.0 m distance from the instrument. The instrument is suitable for operation in indoor areas only.  The operating location must be well-ventilated and have an air exhaust.  A running water connection must be available at a maximum distance of 2.5 m. This connec-tion must also be easily accessible after installing the instrument. A waste water connection must be available at a maximum distance of 2 m. This connection must be connected to the instrument with constant outlet hose slope.4.1 Installation site requirements A connection to an external exhaust system, a technical room ventilation system and an integrated exhaust system with an active carbon filter reduce the concentration of solvent vapor in the room air. The active carbon filters must be used for connecting to an external exhaust system as well. Compliance with this is mandatory.  The instrument operator bears responsibility for complying with workplace limits in accordance with the hazardous substances ordinance and the measures necessary for this, including documentation. A grounded power supply socket must be available at a maximum distance of 3 m.4. Installation and Starting Up Installation and leveling are carried out as part of the instrument installation by per-sonnel authorized by Leica only! Use 4 qualified persons when lifting the device; grab under the frame at all corners and lift evenly.DRAFTDRAFTDRAFT4. In2014 08 21nstallation and leveling are carried out as part of the instrumsonnel authorized by Leica only!Use 4 q alified persons hen lifting the de ice grab nder t2014 08 21
28 Instructions for Use V 0.5 RevC - 08/20144. Installation and Starting Up4.2 Running water connectionThere is the option of choosing between two connection variants.The device must be programmed to the connection variant used (see Chap. 6.5).The following installation instructions apply for both types of connections: Remove the rinsing water supply hose (7) from the packaging, being careful of the two gaskets (4). Insert one gasket (4) into the screw connection (6) on the instrument. Keep other gaskets as replacements. Insert the filter screen (3), as shown in Fig. 5, into the retaining ring (5) that is fastened to the water tap. Do not use another gasket since the filter screen acts as a sealing simulta-neously.Fig. 5DRAFTDRAFTDRAFTng Upng Upp2014-08-21s the option of choosing between two connection variants.device must be programmed to the connection variant usedee2014-08-21
29Leica HistoCore SPECTRA ST4. Installation and Starting UpIf all water flow cuvettes (6 running water stations) are to be connected to a joint running water connection, both supply hoses (see Fig. 6) are used at the same time:125341Rinsing water supply hose 1 (2.5 m) Order No.: 14 0474 323252Pressure hose (1.5 m) Order No.: 14 0512 493343Rinsing water supply hose 2 (2.5 m) Order No.: 14 0474 323254Y piece Order No.: 14 3000 003515Filter Order No.: 14 0512 49331Fig. 64.2.1 Joint connection of all 6 rinsing water stationsDRAFTDRAFTDRAFT4.In2014-08-21low cuvettes (6 running water stations) are to be connected low cuvettes (6 running water stations) are to be connected , both supply hoses (both supply hoses (see Fig.see Fig.66) are used at the same time:) are used at the same t
30 Instructions for Use V 0.5 RevC - 08/20144. Installation and Starting Up4.2.2 Combined connection 4+2 rinsing water stationsIf the main connection (4 rinsing water stations) is to be connected to fresh water and the sec-ondary connection (2 rinsing water stations) is to be connected to a supply in the laboratory with distilled or desalinated water (aqua dest. or demineralized water), proceed in accordance with the following connection diagram:Fig. 71Rinsing water supply hose 1 (2.5 m) Order No.: 14 0474 323252Pressure hose 3 (1.5 m) Order No.: 14 0512 493343Rinsing water supply hose 1 (2.5 m) Order No.: 14 0474 323254Filter Order No.: 14 0512 493311234DRAFTDRAFTDRAFTng Upng Upgp2014-08-21nection (4 rinsing water stations) is to be connected to freshnection (4 rinsing water stations) is to be connected to freshction (2 rinsing water stations) is to be connected to a supption (2 rinsing water stations) is to be connected to a suppr desalinated water (aqua dest or demineralized water) pror desalinated water (aqua dest or demineralized water) pro
31Leica HistoCore SPECTRA ST4.2.3 Wastewater connection The instrument has a passive wastewater outflow. The lab outflow siphon must therefore be located at least 50 cm under the wastewater connection of the instrument.The outlet hose (1, Fig. 8) must be routed at a constant slope and must not be elevated.4. Installation and Starting UpFig. 81DRAFTDRAFTDRAFT4.In2014-08-21rument has a passive wastewater outflow. The lab outflow siument has a passive wastewater outflow. The lab outflow siat least 50t least 5cm under the wastewater connection of the instrcm under the wastewater connection of the instr
32 Instructions for Use V 0.5 RevC - 08/20144. Installation and Starting UpUse only the power cable provided, which is intended for the local power supply. Connect the power cable to the power input socket on the rear panel of the instrument (Fig. 9). Plug the power plug into a grounded power socket.Fig. 9Before connecting the instrument to the power supply, make sure that the main switch on the front right side of the instrument is in the OFF ("0") position. 4.3 Electrical ConnectionFig. 1012 Switch on the power switch (1, Fig. 10).  After a short period of time, the operating switch lights up orange (2, Fig. 10); once the software has completely started, it lights up red and the instrument is in standby mode. The operating switch can then be operated (see Chap. 4.5).DRAFTDRAFTDRAFTng Upng Upp2014-08-21ly the power cable provided, which is intended for the local p2014-08-21
33Leica HistoCore SPECTRA ST4. Installation and Starting Up4.4 Exhaust air connection4.3.1 Using an external uninterruptible power supply (UPS)The UPS power cable must always remain in the power socket in the lab, even in the event of a power outage. Otherwise grounding of the instrument can-not be ensured!A connection to an external exhaust system and an integrated exhaust system with an active carbon filter reduce the concentration of solvent in the room air and must be used. The cuvettes must be covered when not us-ing the instrument to prevent the unneces-sary evaporation of the reagents.When working with hazardous materials, compliance with the workplace limit values according to the ordinance on protection from hazardous substances must be inspect-ed by the operator. Connect one end of the exhaust hose (1, Fig. 12) to the exhaust port (2, Fig. 12) on the top side of the instrument. Connect the other end to an exhaust air device installed in the lab.An interruption of the staining process can be avoided in the event of a temporary power failure by connecting a battery-buffered uninterruptible power supply (UPS). The UPS should enable an output of at least 1350 VA for the duration of 10 min-utes. The UPS must be designed for operating voltage at the installation location. The connection is carried out by connect-ing the SPECTRA ST power cable to the UPS power output socket. The UPS is connected to the power socket in the lab.Fig. 11Fig. 1221DRAFTDRAFTDRAFT4.In2014-08-21An interruption of the staining processAn interruption of the staining processevent of a temporary power failure bynt of a temporary power failure by201
34 Instructions for Use V 0.5 RevC - 08/20144. Installation and Starting Up4.5 Switching the instrument on and offThe instrument must be connected to a grounded power socket. For additional electrical fuse protection, connecting the SPECTRA ST to a socket with a residual current circuit breaker (RCCB) is recommended.If using the oven is programmed in the staining program as the first step, the program can be marked "not startable" after switching on the instrument since the oven has not yet reached operating temperature. As soon as the operating temperature is attained, the program is displayed as startable.  Switch the power switch on the front right side at the bottom of the instrument to ON ("I"). (See 1, Fig. 13)  A few seconds after switching on the power switch, the operat-ing switch is illuminated in orange (Fig. 14). The software's start process ends when the operating switch illuminated in red. To start the instrument, press the operating switch illuminated in red. During initialization, a verification of all stations ("fill level scan") is carried out automatically.  The operating switch is illuminated in green whenever the instru-ment is ready to start. After completing the initialization phase, the main menu appears on the screen (see Fig. 15).Switching off the instrument To switch the instrument into standby mode (e.g. overnight), press the operating switch. It then illuminates in red. For cleaning and maintenance, also switch off the instrument on the power switch (see 1, Fig. 13).Fig. 13Fig. 14Fig. 15Pushing the operating switch in the orange phase does not start the instrument.During the instrument setup or if no reagents are added, non-filled stations are identi-fied and highlighted on the screen (see Chap. 6.2.2)1DRAFTDRAFTDRAFTng Upng Uppinstrument must be connected to a grounded power socket. For arotection, connecting the SPECTRA ST to a socket with a resaker (RCCB) is recommended
35Leica HistoCore SPECTRA ST5. Operation5.1 User interface – overview The SPECTRA ST is programmed and operated using a color touchscreen. The screen ap-pears as follows after switching on if there is no staining process (program) running.Fig. 166312541Status bar 4Button for the SPECTRA CV process display2Process status display 5Input drawer status display3Output drawer status display 6Main menu (see Chap. 5.5)DRAFTDRAFTDRAFT2014-08-21CTRA ST is programmed and operated using a color touchsCTRA ST is programmed and operated using a color touchss follows after switching on if there is no staining process (pfollows after switching on if there is no staining process (p
36 Instructions for Use V 0.5 RevC - 08/20145.2 Status bar elementsFig. 171Current date2Local time3The "Remote Care access" symbol indicates that this instrument is connected to the Leica Remote Care Service via a network connection.4The "process" symbol indicates that staining processes are currently active.5This "user" symbol indicates that the instrument is in user mode, which enables simpli-fied operation of the instrument without a password. 6The operation of this instrument in "Supervisor Mode" is displayed by this symbol. This mode provides additional operation and adjustment options for trained staff. Access to this mode is password-protected.7If warnings and notes are displayed during operation, the symbol depicted appears. Pressing this symbol allows the last 20 messages to be called up again.8If alarms and error messages are displayed during operation, this alarm symbol appears. Pressing this symbol allows the last 20 messages to be called up again.123567 845. OperationDRAFTDRAFTDRAFT2014 08 212014 08 213
37Leica HistoCore SPECTRA ST5.3 Process status display All slide racks located in the process (3) are displayed in the main window (Fig. 18).  The title bar of the main window (2, Fig. 18) indicates the instrument type [SPECTRA ST] and lists the currently bootable staining programs with the defined abbreviations and the color assigned to the slide racks.Fig. 185. Operation123To display an active staining process, the upper part of the clip is displayed symboli-cally in the respective color (3, Fig. 18). If the number of racks in the process exceeds the maximum that can be displayed in the main window (max. 9), you can scroll through the display area vertically using the keys (1, Fig. 18). If one of the buttons is grayed out, it is disabled and there are no other elements in an area that is not shown.DRAFTDRAFTDRAFT2014 08 21
38 Instructions for Use V 0.5 RevC - 08/201412345.3 Process status display (continued)Fig. 195. OperationIf the SPECTRA ST staining machine is connect-ed to the SPECTRA CV robotic coverslipper per-manently, the combination of both instruments represents an instrument unit (workstation). This enables an interruption-free workflow from the staining process up to the removal of the fin-ished cover slipped slides.The current process status of both instruments can be shown on the screen of the SPECTRA ST staining machine. Pressing the "SPECTRA CV" (3, Fig. 20) or "SPEC-TRA ST" button allows you to change between the status displays of the staining machine and robotic coverslipper.The progress display is divided into two sections in workstation mode with a connected SPECTRA CV. The upper section displays the progress in the stainer.The lower area shows the coverslipping prog-ress in the SPECTRA CV (see Chap. 6.7.5).1Abbreviation of the program2Current position of the slide rack in the instrument3Progress display of the entire stain-ing process4Estimated remaining time at the current station (hh:mm)5Remaining time until the end of the program (hh:mm)Each ongoing staining process is il-lustrated by a rack clip symbol. It is shown in the same color as the actual rack clip. Various information is dis-played on the clip symbol (see Fig. 19). Fig. 19 shows the status display on the SPECTRA ST without connected ro-botic coverslippers. For displaying the status display in workstation opera-tion, see Chap. 6.7.5.4DRAFTDRAFTDRAFT2014-08-21201Each ongoing stailustrated by a rachith8-2108
39Leica HistoCore SPECTRA ST5.4 Displaying the drawers The stations displayed using the direction of the arrow pointing into the instrument (1, Fig. 20) symbolize the input drawer. The stations displayed using the direction of the arrow pointing out of the instrument (2, Fig. 20) symbolize the output drawer with five positions each. The respective drawer is opened or closed automatically by pressing the drawer button (4 or 5, Fig. 20).  The device automatically recognizes if slide racks are inserted or removed when the drawer is closed. The slide racks located in the input or output drawer are shown on the screen with the respective slide rack handle color and the assigned program abbreviation. Available positions are shown in white and without a label.Fig. 205. Operation132The lower area of the main window illustrates the status of the input and output drawers. 45DRAFTDRAFTDRAFT2014-08-212014-08-21rea of the main window illustrates the status of the input anrea of the main window illustrates the status of the input an08 21
40 Instructions for Use V 0.5 RevC - 08/20145.5 Main menu-overviewThe main menu is located on the left side of the display (see Fig. 18), which is divided into sec-tions as described below. This menu is visible in all submenus and allows switching to another submenu at any time.The "process status display" displays the current status of all racks located in the process. Here, the respective clip of the rack is displayed symbolically with the respective color. This display shows the standard display.The "bathlayout" displays the top view of all stations within the instru-ment. The individual reagent stations are displayed with reagent names, station numbers and slide racks located in the process.After activating the "program list", all staining programs available in the instrument are displayed in list form. The menu enables re-entering and changing staining programs, their prioritization and the creation of the bathlayout.After activating the "reagent list", all previously entered reagents are displayed in list form. The menu enables the modification or re-entering of staining reagents, e.g. for integrating new staining programs. The reagents must be entered before creating the program.Basic settings can be configured in the "Settings" menu. The language version, date and time as well as oven temperature and other parameters can be adjusted to the local requirements here.In the "User Settings" menu, a password can be set up to prevent modifications to the programs and reagent lists by unauthorized persons ("Supervisor mode"). However, the instrument can be used without a password in "User Mode".5. OperationDRAFTDRAFT2014-08-21u is located on the left side of the display u is located on the left side of the display ((see Fig.see Fig.18)), which, whichbed below. This menu is visible in all submenus and allows sbed below. This menu is visible in all submenus and allows sy timey time
41Leica HistoCore SPECTRA ST5. Operation5.5.1 The keyboard1Title bar 8Cancel (entries are not saved!)2Input field3Delete most recently entered character 9Upper and lowercase (holding the button activates caps lock, displayed by coloring the button red. Pressing again re-activates lowercase.)4Confirmation5Move cursor to left or right6Space key7Special character toggle button (Fig. 22)341568 729Fig. 21A keyboard appears (Fig. 21) for required entries (e.g. for programming, creating pro-grams or password entry). It is operated using the touch screen. Note that the keyboard display depends on the configured language.DRAFTDRAFTDRAFTeyboard appearsFig.2required entries (e.g. for programs or password entry). It is operated using the touch screen. 2014 08 21Note that the ke board displa depends on the config red lang a2014 08 21
42 Instructions for Use V 0.5 RevC - 08/20145. Operation5.5.1 The keyboard (continued) To enter a special character or umlaut, etc. not included in the special character keyboard (Fig. 22), hold the corresponding normal button on the keyboard.  Example: Holding the normal character "a" opens the selection options displayed in Fig. 23. Select the required character from the new single-line keyboard by pressing it.Fig. 23Special character keyboardOther special charactersFig. 22The following lengths are possible for passwords and designations: Reagent names: max. 24 characters / reagent abbreviations: max. 10 characters Program names: max. 24 characters / program abbreviations: max. 10 characters Passwords: min. 4 to max. 10 charactersDRAFTDRAFTDRAFT2014-08-21cter keyboardcter keyboard
43Leica HistoCore SPECTRA ST5. OperationStandard user:The standard user does not need a password and can use the completely configured instrument for all routine applications. It is not possible for this user group to modify programs and settings.Fig. 245.6 User settingsThis menu can be used to configure the appropriate access level. A distinction is made between    21DRAFTDRAFTDRAFT2014-08-21This menu can be used to configure the appropriate accesThis menu can be used to configure the appropriate accesmade betweenmade betwe  
44 Instructions for Use V 0.5 RevC - 08/20145. OperationFig. 255.6 User settings (continued)The password configured at the facto-ry should be changed during the initial setup.To activate supervisor mode, proceed as follows:  Press the "Supervisor" button (1, Fig. 24). Then, a keyboard (Fig. 25) is displayed which can be used to enter the password. The entry is finished by hitting "OK" and the entered password is checked for validity.  The current user status is displayed with the respective symbol in the status bar on the top right.To change the password, press the "Change password" (2, Fig. 24) button and enter the old password. Then, enter the new password twice using the keyboard and confirm by hitting "OK".A password must have at least 4 characters and may have up to 10 characters.Supervisor:Supervisors have the same access options as the standard user, but can also create programs and perform the instrument setup functions. Therefore, supervisor access is password-protected.DRAFTDRAFTDRAFT2014-08-21pervisor:pervisor:pervisors have the same access options as the standard uspervisors have the same access options as the standard uso create programs and perform the instrument setup functio create programs and perform the instrument setup functi
45Leica HistoCore SPECTRA ST5. OperationFig. 265.7 Basic settingsService technician:The service technician can access system files and carry out basic settings and tests. Access to this service menu is only possible for technicians trained by Leica and certified for this instrument type.Touching the gear symbol (1, Fig. 26) opens the "Parameters" menu (Fig. 26). Basic instrument and software settings can be configured in this menu. Touching one of the symbols (e.g. 2, Fig. 26) selects it and labels it with a red frame. The respective settings window is displayed in the right area of the screen. The individual submenus are described below.Changing the settings, for example when setting up the instrument for the first time, is only possible in supervisor mode (see Chap. 5.6).12DRAFTDRAFTDRAFT2014-08-21Service technician:Service techniciaThe service technician can access system files and carry The service technician can access system files and carry tt
46 Instructions for Use V 0.5 RevC - 08/20145. Operation5.7.1 Language settings The language selection menu is displayed by pushing the symbol for the lan-guage (2, Fig. 26). This menu contains an overview of all languages installed in the instrument and allows the desired display language to be selected. Select the desired language and confirm by hitting "Save". The screen display and all messages and labels are displayed immediately in the currently configured language.A Leica service technician can add other languages using Import (see Chap. 5.7.7). Fig. 275.7.2 Country-specific settingsBasic display settings can be carried out in this menu.Unit of temperature: Configure the temperature unit (1, Fig. 27) in Celsius or Fahrenheit. To do so, position the slider to the desired unit.Time format: The time display (2, Fig. 27) can be changed from a 24-hour display to a 12-hour display (a.m. = morning/p.m. = afternoon) using the slider.Date format:  Configure the date display (3, Fig. 27) to in-ternational, ISO or US format by pushing the corresponding radio button next to the sample format. The activated setting is labeled by a red border (4, Fig. 27) Pushing the "Save" button saves the settings2431DRAFTDRAFTDRAFT2014-08-21The language selection menu is displayed by pushing thehe language selection menu is displayed by pushing theguageguage ( 2,Fig.F266). This menu contains an overview of all laThis menu contains an overview of all lathe instrument and allows the desired display language tothe instrument and allows the desired display language to
47Leica HistoCore SPECTRA ST5. Operation5.7.3 Date and timeThe current date and local time can be configured in this menu by rotating the individual rollers. Pushing the "Save" button saves the settingsIn the 12-hour display, a.m. (morning) and p.m. (evening) is displayed under the hour digits to enable a correct set-ting.The time and date settings cannot de-viate more than 24 hours from the sys-tem time configured at the factory.Fig. 28This menu can be used to select the alarm and signal tones and adjust the vol-ume. The current setting for alarm and signal tones is displayed after calling up the menu. 5.7.4 Alarm and signal tonesDRAFTDRAFTDRAFT2014-08-21The current date and local time can be configured in thiThe current date and local time can be configured in thiindividual rollers.individual rollers
48 Instructions for Use V 0.5 RevC - 08/20145. Operation5.7.4 Alarm and signal tones (continued)Alarm type 1 - Note: Signal tones are issued if a notification is displayed on the screen. You can select from a list of 6 sounds. To change the settings, press the "Edit" button (3, Fig. 29) .Alarm type 2 - Error: Alarm sounds are output if a warning or error message is displayed on the screen. This requires immediate intervention from the user. You can select from a list of 6 sounds. To change the set-tings, press the "Edit" button (4, Fig. 29). The volume setting for alarm sounds is adjusted using the "Volume" roller. Six different sounds are available for the alarm types. The "Test" button (7, Fig. 29) can be used to listen to the respective sound. Pressing the "Save" (8, Fig. 29) button saves the settings. The "Cancel" button (6, Fig. 29) is used to close the selection window without applying the settings.Fig. 291234768768DRAFTDRAFTDRAFT2014-08-212014 08 2108
49Leica HistoCore SPECTRA ST5. OperationThe temperature of the oven and its operation mode can be configured in this menu. The current oven settings are displayed after calling up the menu.Temperature: Rotating the roller can configure the target tem-perature of the oven from 40 °C to 70 °C in 5 ° in-crements.Operation mode: For the operation mode, you can choose be-tween: Heating the oven when starting a product ("Program start") or  Starting the oven when switching on the in-strument ("Permanent").  The slider can be brought to the corresponding position to change the settings. Settings are saved by pressing the "Save" button.5.7.5 Setting the ovenThe password-protected user mode "Supervisor" is required to save the changes. In the simple user mode, the "Save" button is shown in gray and is inactive. Validated Leica programs can be operated both with and without an oven step (see Chap. 5.9.2). If an oven step is activated in a validated Leica program, the oven tem-perature cannot be changed for all other programs and remains preset at 70 °C.  We recommend using "Permanent" as a setting to prevent repeated waiting times caused by heating the oven. Fig. 30Changing the oven temperature will always have a potential impact on the staining result. DRAFTDRAFTDRAFT2014-08-21The temperature of the oven and its operation mode can be cThe temperature of the oven and its operation mode can be cThe current oven settings are displayed after calling up theThe current oven settings are displayed after calling up the
50 Instructions for Use V 0.5 RevC - 08/20145. Operation5.7.6 Movement speed - up/down movement (agitation)This menu is used to configure the movement speed of the retaining frame for slide racks. The slide rack clips are on the retaining frame which moves back and forth in the staining process (agitation). The current setting is displayed after calling up the menu.Speed: Rotating the "Speed" roller can be used to configure the agitation frequency in 5 steps (0= agitation disabled, 5= highest speed). Higher values mean a higher agitation frequency. Settings are saved by pressing the "Save" button.The agitation speed for user-defined programs can only be changed if no validated Lei-ca program is active. In this case, the roller is displayed in black and active. Agitation is the default for validated Leica programs and cannot be changed. The roller is grayed out and inactive.Fig. 31Agitation helps stir the added reagents during ongoing staining processes.DRAFTDRAFTDRAFT2014-08-21is menu is used to configure the movement speed of the is menu is used to configure the movement speed of the de racks. The slide rack clips are on the retaining frame whde racks. The slide rack clips are on the retaining frame whrth in the staining process (agitation)rth in the staining process (agitation
51Leica HistoCore SPECTRA ST5. Operation5.7.7 Data managementIn this menu, the data, settings and event logs (log files) can be exported. A USB memory stick connected to one of the USB sockets on the front side of the instru-ment (7a, Fig. 2) is required for all exports and imports (except for remote software updates).Fig. 3212345User export (1, Fig. 32)The "User export" function is used to save various information on a connected USB memory stick (see 7a, Fig. 2). The following files are transferred: All defined programs and reagent lists as a packed and encrypted Zip file Event log (of the last 30 working days) RMS information in CSV formatUser-defined programs and the reagent list can be transfered to another SPECTRA ST by the "Import" function (3, Fig. 32).After successfully setting up the instrument, we recommend exporting the data to be able to access it if the instrument has to be set up again.DRAFTDRAFTDRAFT2014-08-21In this menu, the data, settings and event logs (log files) cthis menu, the data, settings and event logs (log files) cmemory stick connected to one of the USB sockets on thememory stick connected to one of the USB sockets on thement (ment7a7aFigF2) is required for all exports and imports (exc) is required for all exports and imports (exc
52 Instructions for Use V 0.5 RevC - 08/20145. OperationThis function enables the data import of the encrypted program and reagent list, additional validated Leica programs and additional language packages from a connected USB memory stick. This data can also be used to equip another SPECTRA ST with the same data using the Export/Import function.  To do this, insert the USB memory stick with the previously exported data into one of the USB sockets on the front side of the instrument. Then, select the "Import" function. The data is scanned.When importing data from a USB memory stick, all programs and reagents previously located on the instrument are overwritten. The password-protected user mode "Supervisor" is required for importing. 5.7.7 Data management (continued)Import (3, Fig. 32)Service export (2, Fig. 32)Along with the files named below, this function also saves technical information for error log analysis and is required for technical instrument diagnostics.The data is stored encrypted and cannot be read out on a PC.Two files are also stored that are merged into a zip file. These files are packed in a ZIP folder unencrypted. They can be read out and used by a service technician authorized by Leica:Error log (of the last 30 days)Content of the ZIP folder:1. Run-Log-Datei mit allen Statusmeldungen in der eingestellten Sprache2. Information from the reagent management system (RMS), in CSV format.DRAFTDRAFTDRAFT2014-08-21t((2,2Fig.Fig323)files named below, this function also saves technical inforfiles named below, this function also saves technical infori d f t h i l i t t di tiidf t hi li t tdi
53Leica HistoCore SPECTRA ST5. Operation5.7.7 Data management (continued)Software update (4, Fig. 32)Software updates and additional language packages may only be run by a service technician authorized by Leica, e.g. for installing. Lab-specific settings are not deleted when updating the software for the SPECTRA ST.Remote software update (5, Fig. 32)This function makes it possible to update the software using a connected network. To do so, the instrument must be integrated into the Leica Remote Care maintenance and diagnostic system.  The new software version is loaded automatically as soon as it is available for this instru-ment. Once the loading procedure has concluded, the button (5, Fig. 32) is shown in black and is activated. Pressing the "Remote software update" button starts the automatic update process when the instrument is idle.The user will be notified about an available software update via a message.The SPECTRA ST software is updated; lab-specific settings are not deleted.DRAFTDRAFTDRAFT2014-08-21pdate pdate (4,4, Fig.g.322))pdates and additional language packages may only be run pdates and additional language packages may only be run b L i f i t llib L i f i t lli
54 Instructions for Use V 0.5 RevC - 08/20145.7.8 Service access5. OperationThis menu gives Leica authorized service technicians access to technical func-tions for diagnostics and repairs to the SPECTRA ST.Fig. 33Access to the service software is locked for all other user groups.5.7.9 Event viewA separate log file is created for each day that the instrument was switched on. This file can be called up by selecting the "DailyRunLog" file in the event view.Fig. 34 In the event view, an event log can be selected from a list of available logs and called up by hitting the "Open" button.The file name is supplemented by the respective creation date in ISO format, which makes it easier to organize. The file is created in the configured lan-guage. DRAFTDRAFTDRAFT2014-08-21his menu gives Leica authorized service technicians acceshis menu gives Leica authorized service technicians accesons for diagnostics and repairs to the SPECTRA ST.ns for diagnostics and repairs to the SPECTRA ST.
55Leica HistoCore SPECTRA ST5. Operation All event entries begin with a time stamp (1, Fig. 37), which indicates the date and time when the entry was created. You can scroll up and down in the list and the log file using the arrow keys (2, Fig. 35).Fig. 355.7.9 Event view (continued)125.7.10 Network settingsThis menu allows you to set the network parameters for connecting to a network. Data can be transferred to a lab information system (LIS) via this network. Leica service organizations can access the instrument's technical data via a service network (Remote Care) for diagnostic purposes and install software updates.The device may only be connected to an available network, for example during the ini-tial installation, by Leica-authorized service technician in cooperation with the local IT department.DRAFTDRAFTDRAFT2014-08-21All event entl event entstamp (stamp 1, Figigthe date ande date and
56 Instructions for Use V 0.5 RevC - 08/20145. Operation5.8 Reagent listFig. 361Reagent name 8Edit selected reagent2Abbreviation of the reagent name 9Create a new reagent3Process class 10 Copy selected reagent4Maximum number of slides 11 Delete selected reagent5Maximum period of use 12 Edit settings of heated cuvettes for the se-lected reagent6Heated reagent cuvette yes/no 13 Activate/deactivate RMS7Insert for special dye yes/no 14 You can scroll through the reagent list using the arrow keys.4 76581210911231131414Open the reagent list by pressing the adjacent button. This displays all defined re-agents in alphabetical order. Furthermore, a suitable reagent of a heated reagent cuvette (optional) (12, Fig. 36) can be assigned (Fig. 37).DRAFTDRAFTDRAFT2014-08-21pen the reagent list by pressing the adjacent button. This dispen the reagent list by pressing the adjacent button. This disgents in alphabetical order. Furthermore, a suitable reagent ents in alphabetical order. Furthermore, a suitable reagent uvette (optional) (uvette (optional) (121Fig363) can be assigned (be assigneFigg3737))
57Leica HistoCore SPECTRA ST5. Operation When setting up the instrument, the reagent list only contains reagents from the prein-stalled Leica programs. Additional reagents can be added or properties of the reagents can be changed as needed in the reagent list.  Creating or editing a reagent requires "Supervisor" mode. The "User" status only al-lows reagent data to be displayed.  The "RMS: On – Off" (13, Fig. 36) allows the reagent management system = RMS to be switched on or off. This system controls the reagent consumption monitoring. We al-ways recommend keeping the RMS switched on and following the instructions for re-placing a reagent (see Chap. 6.3). It is not possible to switch off reagent monitoring for the Leica staining kit reagents. Failure to adhere to the specified intervals can have a negative effect on the staining quality. The RMS only works reliably if the data has been stored by the user correctly in advance.  The manufacturer assumes no liability for the staining results in case of errors when entering the reagent data. The user cannot edit Leica-validated reagents. 5.8 Reagent list (continued) Select the desired reagent in the reagent list by touch-ing it. Press the "Heated reagent station" (12, Fig. 36) button to open the settings menu (Fig. 37). Set the slider (1, Fig. 37) to "Yes" to activate the heated reagent station. Select the operation mode (2, Fig. 37). Configure the temperature using the roller (3, Fig. 37). Save the entries with the "Save" button or close the menu with the "Cancel" button to close the menu without applying the entries.5.8.1 Define heated reagent (optional)231Reagents like xylene, xylene substitute, alcohols and solutions containing alcohol may not be defined as a heated reagent! Fig. 37DRAFTDRAFTDRAFTWhen setting up the instrument, the reagent list only contains rstalled Leica programs.Additional reagents can be added or properties of the reage2014 08 212014 08 21
58 Instructions for Use V 0.5 RevC - 08/2014 To add a new reagent to the reagent list, press the "New" (see 9, Fig. 36) button. It opens the entry window for the new reagent to be created (see Fig. 38).  The following parameters can be entered:Reagent namePush the "Reagent name" (1, Fig. 38) button and enter a unique reagent name that has not yet been used using the onscreen keyboard. You can enter up to 24 characters (including spaces).AbbreviationThe "Abbreviation" (2, Fig. 38) button can be pressed to enter a unique reagent name that has not yet been used using the onscreen keyboard (maximum 10 characters, including spaces).Creating or editing a reagent requires "Supervisor" mode. The "User" status only allows reagent data to be displayed.5.8.2 Creating a new reagentFig. 38425361785. OperationDRAFTDRAFT2014-08-21g or editing a reagent requires "Supervisor" mode. The "Userent data to be displayed.2014-08-21
59Leica HistoCore SPECTRA STMax. specimen slides:The roller (3, Fig. 38) is used to configure the maximum number of slides that can be processed with this reagent before a reagent change is requested. By rotating the rollers, values between 1 through 3999 are permitted. Max. days: The maximum number of days (4, Fig. 38) that the reagent can remain in the instrument is con-figured by rotating the roller. Values from 1 through 99 are permitted when entering figures. Holder for 5 specimen slides:If a reagent cuvette is equipped with an element for special staining to enable a smaller re-agent volume, using the slide rack for 5 slides only is possible in this cuvette. Then, you must set the slide switch to "Yes". Using a slide rack for 30 slides in this cuvette is now disabled.5.8.2 Creating a new reagent (continued)Using the element for special staining in one or more reagent cuvette(s) requires switching to the "Yes" position. If the switch is not set correctly for the affected reagent cuvette(s), it can cause a slide rack for 30 slides to be used in this cuvette, which inevi-tably leads to a serious equipment failure with possible specimen loss.5. OperationProcess class:Assigning the reagents to process classes (6, Fig. 38) is required since, along with the prioriti-zation of programs, it is essential for calculating the individual positions of the bathlayout (see Chap. 5.8.2). Save the entries with the "Save" (7, Fig. 38) button or close the entry window without applying the entry using the "Cancel" (8, Fig. 38) button.Subsequently changing a process class is no longer possible after the initial save. The reagent can only be deleted and re-created or copied and then changed. DRAFTDRAFTDRAFT2014-08-21men slides:men slides:3, , Fig.Fig.388) is used to configure the maximum number of slides) is used to configure the maximum number of slidest b f t h i t d B t ti tht b f t h i t d B t ti th
60 Instructions for Use V 0.5 RevC - 08/20145. OperationFig. 3912231The preferred zone for dewaxing reagents is the left side of the bathlayout.2The preferred zone for staining solutions or differentiating solutions are the two rows to the left and right of the rinsing water stations. 3The preferred zone for draining reagents is the right side of the bathlayout.5.8.3 Process classesProcess classes must be assigned correctly since it can otherwise cause delayed workflows in the staining processes and deviating or inadequate staining results.The reagent process classes of preinstalled Leica programs are already defined and cannot be changed.DRAFTDRAFT2014 08 21s classes must be assigned correctly since it can otherwkflows in the staining processes and deviating or inadequate sta2014 08 21
61Leica HistoCore SPECTRA ST5. Operation5.8.3 Process classes (continued)Process class Description Example of reagentsDewaxing(Dewaxing) Solvents that remove the paraffin and, following the paraffin removal, the subsequent graded alcohol series, at the beginning of a staining program. Xylene Xylene substitute Graded alcohol se-ries: 100 %, 95 %, 70 % alcoholNeutralizing(Neutralizing) Reagents that have little or no effect on the stain application or the stain development and that have a roughly neutral pH value. Example: Aqua dest. step before a stain-ing step. Aqua dest. (demin-eralized)/fresh water (not in rinsing water stations!) Thinning with aqua dest. Aqueous alcoholic solutions (e.g. 70 % ethanol)Staining (Staining) Staining solutions Wood stains Oxidizing agents (e.g. Periodic acid of the PAS dye) All staining solutions Wood stains and oxi-dizing agentsDifferentiating (Differentiating) Reagents that remove excess color from the product.  Reagents that are required for the stain development or a color change.Low pH value: HCL solution (alcoholic or aqueous) Acetic acidHigh pH value: Ammonia water Scott's tap water Blueing Solution Blue Buffer Lithium CarbonateNo two successive rinsing water steps can be programmed (rinsing water step for aqua dest. or vice versa). If the sequence of the program steps is to occur in this way, one of the steps has to be defined as a reagent assigned to a process class (e.g. neutralizing).DRAFTDRAFTDRAFT2014 08 21No two successive rinsing water steps can be programmed (rinsest. or vice versa). If the sequence of the program steps is to ohe steps has to be defined as a reagent assigned to a process cl2014 08 21
62 Instructions for Use V 0.5 RevC - 08/20145. Operation5.8.3 Process classes (continued)Process class Description Example of reagentsDehydrating (Dehydrating) Reagents of the ascending alcohol series, at the end of a staining program. Subsequent solvent steps (xylene or xy-lene substitute), at the end of a staining program, for preparing the coverslipping operation.Dehydration: Ascending alcohol se-ries: 70 %, 95 %, 100 % alcoholPreparing the coverslip-ping operation: Xylene Xylene substituteNo class (no class)Reagents that do not require any special assignment in the bathlayout (see information below).The following must be observed for preparing the coverslipping operation: The solvent used at the end of the program and in the following coverslipping process must be compatible with the mountant.The correct assignment of the process classes is necessary so that the optimal bathlay-out can be calculated and long transport paths and times can be avoided. Basic rules of automatic creation of the bathlayout include: The transfer from the left cuvette field to the right cuvette field should occur via a rinsing water station whenever possible. Programs that do not contain a rinsing water station as a step use the dry transfer sta-tion for this transfer. Staining reagents that require a subsequent rinsing water step are positioned adja-cent to the water flow cuvettes (Zone 2, Fig. 39). Reagents for which "No class" has been assigned as a process class are set at any position during the automatic creation of the bathlayout. Instead of the "No class" assignment, we recommend assigning these reagents to ei-ther the "Differentiating" or "Neutralizing" project class so that adjacent stations in the bathlayout can be taken into account for series.DRAFTDRAFTDRAFT2014-08-21DescriptionExamp Reagents of the ascending alcohol series,Reagents of the ascending alcohol series, DehydDehyd
63Leica HistoCore SPECTRA ST5. Operation5.9 Staining programThe list of the staining programs installed on the SPECTRA ST is opened by push-ing the "Programs" button.A distinction is made between two types of staining programs:  Leica staining programs (preinstalled) (see Chap. 5.9.2) User-defined staining programs (see Chap. 5.9.4)67108911432151The program is taken into account in the current bathlayout.7Create a new program2Assigned program color 8Copy selected program3Program abbreviation 9Delete selected program4Program name 10 Assign a color to the selected program5Preinstalled Leica program 11 Define bathlayout6Edit programFig. 39DRAFTDRAFTDRAFT2014-08-21The list of the staining programs installed on the SPECTRAThe list of the staining programs installed on the SPECTRAing theing the "Programs"rogram button.button.A distinction is made between two types of staining prograA distinction is made between two types of staining progra
64 Instructions for Use V 0.5 RevC - 08/20145. OperationFig. 415.9.1 Staining program - general settings In the program list (Fig. 40), select the program that is to be assigned a slide rack handle color by touching the correspond-ing entry. Pressing the "Color" (10, Fig. 40) button is used to display a selection field (Fig. 41) that allows assigning the slide rack handle color to the selected program.  A slide rack handle color can be assigned to each program. Editing the staining intensity and rack handle color assignment requires the "Supervi-sor" user status. All available colors are displayed in Fig. 41. If an ab-breviation is entered in the color field, this color has already been assigned to a program. If an already assigned color is selected, a dialog box appears with a security prompt indicating that the existing assignment will be undone. This can be con-firmed with "OK" or aborted with "Cancel". Select a color that has not been assigned previously. "Save" is used to assign the color and close the dialog. "Cancel" is used to close the dialog without applying the changes.The color white is a wildcard color. When selecting a white clip for the slide rack, a program selection window opens in which a color has to be assigned to the white clip. DRAFTDRAFTDRAFT2014 08 21slide rack handle color can be assigned to each program.ting the staining intensity and rack handle color assignment reor" user status2014 08 21
65Leica HistoCore SPECTRA ST5. Operation5.9.2 Leica staining programs (preinstalled) Leica staining programs require the use of the specific Leica reagent kit.  The individual program steps of the Leica staining program cannot be shown, edited, copied or deleted. If the Leica staining program provides for it, the oven step can be enabled or disabled. Likewise, the last program step for unloading the racks into the output drawer or for transferring them to the SPECTRA CV robotic coverslipper can be programmed. Leica staining programs are preinstalled at the factory and have had their function and stain-ing properties tested. They ensure a uniform staining quality for a specified number of slides.  Leica staining programs are labeled in the last column with a cursive Leica "L" (5, Fig. 40).Fig. 42123If a paraffin removal step is not provided as the first step for the Leica staining program, then the oven step (see 1, Fig. 42) must not be enabled, as otherwise the specimens could be destroyed!DRAFTDRAFTDRAFT2014-08-21aining programs are preinstalled at the factory and have had tning programs are preinstalled at the factory and have had terties tested. They ensure a uniform staining quality for a speerties tested. They ensure a uniform staining quality for a speii lbldi h l l ih iii lbldi h l l ih i
66 Instructions for Use V 0.5 RevC - 08/20145. Operation5.9.3 Adapting the Leica H&E staining programIf "Edit" (6, Fig. 40) is selected in the program list, a dialog opens that enables the staining intensity to be set. The staining intensity values can be set by turning the rollers. Smaller numerical values cause a lower staining intensity; higher numer-ical values cause a larger staining intensity.  A rack handle color can be assigned to the program (see Chap. 5.9.1). Use "Save" to save the settings and close the dialog. Use "Cancel" to close the dialog without sav-ing changes.Fig. 43With the Leica H&E staining program, the staining intensity can be adjusted for hema-toxylin and eosin. Other Leica staining programs do not allow for any adjustments to the staining intensities.After the user adjusts the staining intensity, the staining result has to be checked with a specimen cycle (trial sections) before the settings are used for patient specimens for clinical diagnostics.Creating a new staining program or editing an existing staining program requires the "Supervisor" user status.The "User" status only allows program steps to be displayed. 5.9.4 User-defined staining programs  Leica can provide neither testing nor a warranty for user-defined programs.  Testing of these staining programs, with the respectively used reagents, must be car-ried out in the lab by the user. To do so, the staining result has to be checked with a specimen cycle (trial sections) before the program is used for patient specimens for clinical diagnostics.DRAFTDRAFTDRAFT2014 08 21e Leica H&E staining program, the staining intensity can belin and eosin. Other Leica staining programs do not allow for anning intensiti2014 08 21
67Leica HistoCore SPECTRA ST5. Operation5.9.5 Creating a new staining program In the list view of the programs, press the "New" button (1, Fig. 44).  A new program window opens.Fig. 441Two empty buttons are shown in the upper area of this window. They are intended for the program name and its abbreviation. Press the "--" button behind the "Pro-gram Name" designation.  An input mask with keyboard appears.  Enter the program name. Press the "OK" button to finish.Proceed as described above to enter the "Abbreviation".Fig. 451To create a new staining program, multiple program steps are added to the program in sequence. DRAFTDRAFTDRAFT2014-08-21In the list view e list view the the "New""New" buttooA new programw program w
68 Instructions for Use V 0.5 RevC - 08/20145. Operation5.9.5 Creating a new staining program (continued)Fig. 46 After a new program has been created, press the "New" button (see 1, Fig. 45). A window opens for defining the program step (Fig. 46). The reagents already predefined by the user are listed in the area on the left (1, Fig. 46). This is marked by selecting a reagent.  The reaction time (hh/mm/ss) of the specimens in the reagent is defined in the area on the right by turning the rollers (2, Fig. 46). The valid setting range goes from 1 second up to 23 hours 59 minutes and 59 seconds. The permitted "Tolerance" (3, Fig. 46) of the step is set under this. If an accurate program step is needed that does not allow chronological expansion of the specified time, the tolerance 0 % must be selected. The tolerance can be selected in 25 % increments up to a maximum expansion of 100 %, i.e. the instrument can extend the step to twice the length of the con-figured time, if needed.123 54 67 DRAFTDRAFTDRAFT2014 08 212014 08 21440
69Leica HistoCore SPECTRA ST5. Operation5.9.6 Inserting a new program step (continued)A program must always be concluded with a final target station step. Either the output drawer (Unloader UNL) or the transfer station (Transfer Station TRA – only in worksta-tion mode) can be selected for transfer to the SPECTRA CV robotic coverslipper A warning message indicates that saving the program without defining the target station as the last step is not possible.Fig. 47A large time tolerance setting is recommended if no negative effects on the staining re-sult are to be expected. This gives the instrument more room to synchronize steps of multiple programs running at the same time. If a check mark is in the "BL" column (4, Fig. 46), it means that this reagent is already inte-grated into the bathlayout. To limit the display to reagents that are already actively used in the bathlayout, enable the radio button "Show only reagents of current bathlayout" (5, Fig. 46). If the "Exclusive" box (6, Fig. 46) is enabled, the selected reagent can be used only for the created program and no other program is available for selection. The program step entry is completed with "OK" (7, Fig. 46).  Depending on need, other program steps can be added in the same way until all staining process steps are illustrated in the program.DRAFTDRAFTDRAFT2014 08 21rge time tolerance setting is recommended if no negative effult are to be expected. This gives the instrument more room tmultiple programs running at the same time2014 08 21
70 Instructions for Use V 0.5 RevC - 08/20145. Operation5.9.7 Resorting a program step The program step is highlighted in red upon selection. Now the "Move" buttons (1-4, Fig. 48) are active.  The "Save" button saves the current status.If an oven step is used as a first program step, a flammable solvent must not be present in the load station of the input drawer under any circumstances.This can cause a detonation in the oven, which can cause the operator to be burned, specimen loss and damages to the instrument and equipment.Fig. 481Press to move the selected program step to the first row.2Press to move the selected program step one row up.3Press to move the selected program step one row down.4Press to move the selected program step to the last row.1234DRAFTDRAFTDRAFT2014-08-21The program step The program step upon selection. Nowpon selection. Now((141Fig4848) are ac) are ac
71Leica HistoCore SPECTRA ST5. Operation5.9.8 Prioritizing programsFig. 49 After all desired staining programs have been entered, the bathlayout has to be generated. To do so, pro-ceed as follows: In the first step, the supervisor should define which programs are to be taken into the bathlayout. The programs are activated via the radio button (see 1, Fig. 49). The position of the program deter-mines its priority for the integration into the bathlayout1Priority: Leica staining programs are always placed at the beginning of the program list. The positions of the Leica staining programs cannot be changed.  The positions of the user-defined programs can be moved.  The user-defined programs with low position numbers are easier to take into account when creating the bathlayout than programs with high position numbers. We recommend positioning user-defined programs with high specimen throughput at the beginning of the program list, following the Leica staining programs.If a higher priority is to be assigned to a staining program, it must be moved higher in the list using the "Move" button: The program is moved to the first row (2, Fig. 49) The program is moved one row up (3, Fig. 49) The program is moved one row down (4, Fig. 49) The program is moved to the last row (5, Fig. 49) Due to the new prioritization, the bathlayout has to be newly created (see Chap. 5.9.9).23456DRAFTDRAFTDRAFT2014-08-21After all desAfter all deshave been ehave been ehas to be geas to be ge
72 Instructions for Use V 0.5 RevC - 08/20145. OperationIntegration of Leica staining programsIf the software detects that a Leica staining program is integrated into the bathlayout, an information message (Fig. 51) opens, prompting the user to scan the Leica reagent kit in the next step.  When prompted by an information message (Fig. 52) on the screen, stop the carton's pack-aging label in front of the RFID sensor on the front of the instrument (1, Fig. 53) to scan it. Likewise, scan the labels of the individual reagent bottles when prompted. 5.9.9 Creating a bathlayoutThe arrangement of the reagent stations in the instrument is calculated using the priori-tized staining programs (see Chap. 5.9.8). These are some things to be observed when doing so: Leica staining programs are taken into account first, Staining and differentiation solutions are placed as close as possible to the water flow cuvettes, The program prioritization and process class assignment are observed, Sequential process steps must be located close to each other. To start calculating the bathlayout, press the "Define bathlayout" button (6, Fig. 49).  Press the "Create bathlayout" button to proceed or the "Cancel" button to return to the program selection.Fig. 50 Be sure to observe the warning mes-sage displayed after pressing the "Define bathlayout" button (Fig. 50)! Procedure for scanning the Leica reagent kit The user has 3 minutes to scan the reagents for the carton's packaging label and 1 minute per reagent bottle. If the time is not used, the user is prompted to restart or resume the scanning process. DRAFTDRAFTDRAFTangement of the reagent stations in the instrument is calculad staining programsee Chap.5.9.8)2014 08 21se are some things to be observed when doing2014 08 21
73Leica HistoCore SPECTRA ST5. Operation11Fig. 53Fig. 54Fig. 51Fig. 52Reagent cuvettes must al-ways be filled outside of the instrument in compliance with the safety information.5.9.9 Creating a bathlayout (continued)The reagent management system (RMS) automatically takes over the following data for the Leica reagents: The use-by date (onboard shelf life), remaining number of slides, max. number of slides, expiration date and the batch number. After scanning each individual re-agent bottle, the instrument prompts the user to fill this into a reagent cuvette and to place it into the in-strument at the specified position (1, Fig. 54). Confirm the correct insertion by touching the specified position on the screen. Repeat these steps for all reagents of the Leica reagent kit.The arrangement of the bathlayout is to be followed exactly. Any deviation can lead to undesired staining results.DRAFTDRAFTDRAFT2014-08-21
74 Instructions for Use V 0.5 RevC - 08/20145. OperationIntegration of user-defined programs5.9.9 Creating a bathlayout (continued)Fig. 56 To create the bathlayout, press the "Create bathlayout" button (6, Fig. 49). Fig. 55Be sure to observe the warning mes-sage displayed after pressing the "Create bathlayout" button (Fig. 55)!  Press the "Continue" button to proceed or the "Cancel" button to return to the program selection. An overview of the bathlayout (Fig. 56) is displayed. The reagent stations to be filled are outlined in orange (Fig. 56). One by one, take the reagent cuvettes out of the instrument, fill them with the respective reagent outside of the instru-ment and return them to the correct position. Touch the corresponding station on the screen to confirm the respective reagent change or refilling. Repeat these steps for all displayed, marked stations.The arrangement of the assignment plan is to be followed exactly. Any deviation can lead to undesired staining results.After scanning and inserting the Leica reagents, the further reagents of the Leica stain-ing program (e.g. xylenes, alcohols) and those of the user-defined programs are pro-cessed in the next step. DRAFTDRAFTDRAFT2014 08 21canning and inserting the Leica reagents, the further reagentprogram (e.g. xylenes, alcohols) and those of the user-definedsed in the next step2014 08 21
75Leica HistoCore SPECTRA ST5. Operation5.9.10 Adjusting a bathlayoutIf you need to adjust the bed layout created by SPECTRA ST, which takes into account all optimized regula-tions, this can be done by means of the function "Adapt Bathlayout".Using this function, station place-ments can be moved to their posi-tions within the bathlayout and/or duplicated.To do so, proceed as follows: In the station assignment view, press the "Adapt Bathlayout" (1, Fig. 57) button. Observe the messages that follow (Fig. 58+Fig. 59) and confirm or press "Cancel" (Fig. 59) to return to the station assignment view.Fig. 58Fig. 5723The automatically and optimally created bathlayout should be adjusted only if special user re-quirements were not taken into account. Each adjustment of the bathlayout can have a negative effect on the specimen throughput and staining result!The following rules must be observed when adjusting the bathlayout: Reagent stations must not be moved from one side of the cuvette field to the other because this causes unnecessarily long transfer times. Duplicate stations should be inserted adjacent to the original station in the bathlayout.41DRAFTDRAFTDRAFT2014 08 21atically and optimally created bathlayout should be adjustedents were not taken into account2014 08 21
76 Instructions for Use V 0.5 RevC - 08/20145. Operation The clipboard can be closed only if no more reagent stations are in it. After changes have been made using the "Adapt Bathlayout" function, an automatic fill level scan is performed!Fig. 6023451 After confirmation, the "Clipboard" (Fig. 60) will open, to which up to 6 reagent stations (1, Fig. 60) can be moved.There are two options for changing the bathlay-out:Move the reagent stations to connect them: To move reagent stations, select them in-dividually in the bathlayout by touching the screen and then tapping an available position in the clipboard.  This moves the reagent station to the clip-board. Finally, select the reagent station in the clipboard by tapping and dragging it to the desired (available) station (e.g. 2, Fig. 57) in the bathlayout. To save your changes, press the "Finish" button and confirm the subsequent message with a "Yes" or "No" to return to the clipboard. To delete the changes, press "Cancel" and answer the subsequent message with a "Yes".Duplicate a reagent station To duplicate a reagent station, select it in the bathlayout by touching the screen. Finally, press the "Duplicate" (5, Fig. 60) button.5.9.9 Adapt Bathlayout (continued)Fig. 59DRAFTDRAFTDRAFT2014-08-21After confirmation, the After confirmation, the ""will open, to which up towill open, to which up to((11Figig6060) can be movedbe moved
77Leica HistoCore SPECTRA ST5. Operation Then, the reagent station will appear in the clipboard with an equivalence symbol () (4, Fig. 57). After this, select the duplicate reagent station in the clipboard by touching the screen and place it in the desired (available) station, near the original station in the bathlayout.  To save your changes, press the "Finish" button and confirm the subsequent message with a "Yes" or "No" to return to the clipboard. To delete the changes, press "Cancel" and answer the subsequent message with a "Yes".Duplicated reagent stations make sense for program steps with a long dwell time in a reagent. Duplicated stations make two equivalent reagent stations available for a program step, which ensures getting a high specimen throughput.Leica reagent stations, marked by an "L" before the reagent name (3, Fig. 57), cannot be duplicatedDuplicated reagent stations can be deleted using the "Delete" button (4, Fig. 60). To do so, mark them in the bathlayout by touching them and pressing the "Delete" button.5.9.9 Adapt Bathlayout (continued)DRAFTDRAFTDRAFT2014 08 21ca reagent stations, marked by an "L" before the reagent namduplicated2014 08 21
78 Instructions for Use V 0.5 RevC - 08/20143976542186. Daily Instrument Setup6.1 Preparing the instrument for daily setupFig. 6116 oven stations 65 unloading stations,24 heated reagent stations (optional) 7Dry transfer station3Left reagent cuvette field 8Rinsing water stations (group of two)4Rinsing water stations (group of four) 95 loading stations5Right reagent cuvette field Fig. 61 shows an overview of the various stations in the cuvette field. Altogether, the cuvette field consists of 36 reagent stations and 6 rinsing water stations.  The max. capacity of each reagent cuvette is 380 ml. When using the optional module with four reagent cuvettes that can be individually heated, 32 reagent stations are available.DRAFTDRAFTDRAFTpppows an overview of the various stations in the cuvette fieldr, the cuvette field consists of 36 reagent stations and 6 rinsing wcapacity of each reagent cuvette is 380ml.2014 08 212014 08 21
79Leica HistoCore SPECTRA ST6. Daily Instrument SetupThe reagent cuvettes are always to be filled or drained outside of the instrument to avoid or reduce the risk of spilling reagents into other reagent cuvettes and onto inte-rior instrument components. Proceed carefully and thoroughly when filling or draining the reagent cuvettes and follow the respectively applicable laboratory specifications. If reagents were spilled or another reagent station has been contaminated, it must be cleaned and re-filled.6.2.1 Preparation and handling of reagent cuvettesTo ensure that everything runs smoothly in the instrument, observe the following notes and proceed as follows.Attaching the reagent cuvette clipCheck whether the reagent cuvette clip is correctly attached to the reagent cuvette. If this is not the case, fasten the clip according to Fig. 62.Filling and draining reagent cuvettes6.2. Daily setup of the instrument Open the instrument cover and remove the covers from the reagent cuvettes. Switch on the instrument. Automatic fill level scan when initializing the instrumentDuring the initialization, fill level scans are automatically carried out in the following areas: Reagent cuvettes Water flow cuvettes Reagent cuvettes of the loading and unloading stations Oven station Heated reagent cuvettes (optional)Before setting up the instrument every day, check the water inlet to the instrument and turn it if necessary.If there are still racks, reagent cuvettes that are insufficiently filled or still covered, and/or water flow cuvettes that are not ready to use in the instrument, this is determined during the automatic fill level scan and displayed when finished. DRAFTDRAFTDRAFT62014-08-21ore setting up the instrument every day, check the water inleurn it if necessary.2014-08-21
80 Instructions for Use V 0.5 RevC - 08/20146. Daily Instrument SetupMaximum fill levelMinimal fill levelCarefully insert the reagent cuvette with clip into the cuvette field so that the clip is on the right side of the reagent cuvette when looking at the cuvette field. This orientation of the clip is recommended also for placing the reagent cuvettes in the loading or unloading station and in heated reagent cuvettes (see Optional Accessories).Correct fill level of the reagent cuvettes To fill the reagent cuvettes, observe the fill level marks inside the reagent cuvettes (see marks in Fig. 62 and Fig. 63). A sufficient filling level is ensured if the level of the reagents is between the maximum and minimum fill level marks (see marks in Fig. 62). If the insert for special dyes (Fig. 63) is to be used in the reagent cuvettes (also heated), first put it into the reagent cuvette and then fill the reagent at least up to the displayed minimum filling level (see mark in Fig. 63). Inserting the reagent cuvette into the bathlayout Select "Bathlayout" in the main menu (see Chap. 5.5) and insert the reagent cuvette into the correct position according to the arrangement of the bathlayout. 6.2.1 Preparation and handling of reagent cuvettes (continued)Fig. 62Correct fill level of the reagent cuvettesMinimal fill levelFig. 63Correct fill level when using the insert for special dyesDRAFTDRAFTDRAFTppp2014-08-21el of the reagent cuvettesel of the reagent cuvetteseagent cuvettes, observe the fill level marks inside the reaeagent cuvettes, observe the fill level marks inside the rea
81Leica HistoCore SPECTRA ST6. Daily Instrument Setup6.2.2 Automatic fill level scanAfter filling and inserting the reagent cuvettes, the automatic fill level scan (1, Fig. 64) should be carried out for verifying that all reagents used have the correct fill level.1Irregularities during the fill level scan are displayed on the screen. Follow the information messages and, for ex-ample, correct the fill level, remove the cover, add reagent cuvettes, etc.To start the fill level scan, proceed as follows: Call up "Bathlayout" in the main menu (see Chap. 5.5).  The "Fill Level Scan" button (1, Fig. 64) is in the lower part of the menu screen.  Press this button to start the fill level scan.Fig. 64 The load and unload stations are not taken into account when creating the bathlay-out. Reagents in the load and unload stations have to be defined and monitored by the user. The reagents in the loading and unloading stations are not monitored by the reagent management system. Therefore the user is responsible for making sure the reagents in these stations are in flawless condition.DRAFTDRAFTDRAFT62014-08-21and inserting the reagent cuvettes, the automatic fill level scand inserting the reagent cuvettes, the automatic fill level scfor verifying that all reagents used have the correct fill levefor verifying that all reagents used have the correct fill leve
82 Instructions for Use V 0.5 RevC - 08/20146. Daily Instrument Setup6.3 Reagent management system (RMS)The bathlayout in the instrument is illustrated by pressing the adjacent menu button. This display shows the current layout of the reagent stations, the rinsing water sta-tions and the loading and unloading stations in the instrument.The bathlayout is empty when the instrument is delivered, because reagents still have not been defined and a bathlayout has not yet been created. If reagents and programs were defined (see Chap. 5.8.1) and the bathlayout was created, the overview shows all stations in the instrument in their real order.Each reagent cuvette shown in the bathlayout contains additional information:  Station number Reagent name A background color Equivalence symbol for a duplicated reagent stationFig. 65DRAFTDRAFTppp2014-08-21bathlayout in the instrument is illustrated by pressing the adbathlayout in the instrument is illustrated by pressing the ads display shows the current layout of the reagent stations, thdisplay shows the current layout of the reagent stations, ths and the loading and unloading stations in the instruments and the loading and unloading stations in the instrument
83Leica HistoCore SPECTRA ST6. Daily Instrument SetupThe background color shows the consumption status of the reagent (Fig. 66). When use progresses from bottom to top, the color column grows and changes color, depending on the consumption status:Green: Consumption status between 0-80 % of the maximum use limitYellow: Consumption status between 80-95 % of the maximum use limitRed: Consumption status between 95-100 % of the maximum use limitAs soon as the "Red" consumption status has been reached, but no later than when the station flashes red, the reagent in question has to be replaced. If this is not done, Leica staining programs are no longer able to start.6.3 Reagent management system (RMS) (continued)Fig. 66DRAFTDRAFTDRAFT62014 08 21background color shows the consumption status of the reagprogresses from bottom to top, the color column grows and chaon the consumption status:2014 08 21
84 Instructions for Use V 0.5 RevC - 08/20146.4 Station featuresSlide reader module (SID):When this station is touched, a note appears saying that this station is the slide reader mod-ule. The "Close" button is used to close the dis-play.Oven stations: The detail view of an oven station shows: The current temperature, The target temperature adjustment and  The operation mode of the 6 oven stations.The "Close" button is used to close the display.Touching a station in the bathlayout will display more information (station details). The follow-ing station types are distinguished by their abbreviation:Fig. 67Fig. 686. Daily Instrument SetupL01-L05 Load stationsSID Slide reading module and title block identification (optional)O01-O06 Oven stations for drying the slides and starting to melt the paraffinR01-R42 Reagent stationsW08-W09W22-W23Rinsing water stations (group of four)W36-W37 Rinsing water stations (group of two)H01-H02H15-H16Heated reagent stations (optional)D01-D02 Dry transfer stationsU01-U05 Unloading stations in the output drawerDRAFTDRAFTDRAFTppp2014-08-21tion in the bathlayout will display more information (station tion in the bathlayout will display more information (station es are distinguished by their abbreviation:s are distinguished by their abbreviatio
85Leica HistoCore SPECTRA STRinsing water stations (group of four):The detail view of a rinsing water station shows all other rinsing water stations that are connect-ed to the same water circuit. The "Close" button is used to close the display.Fig. 696. Daily Instrument Setup6.4 Station features (continued)Rinsing water stations (group of two): When you touch a group-of-two rinsing wa-ter station, an information window opens that shows the 2 water stations, which are connect-ed to the second water circuit with, for example, distilled water or demineralized water (1, Fig. 70) or rinsing water (2, Fig. 70) .  Depending on the connected supply, the cor-responding selection will have to be made in this menu.The correct assignment and connec-tion of the water flow cuvettes is ab-solutely necessary for achieving good staining quality.Fig. 70 To install an additional running water connection, see Chap. 4.2. To take over the setting, press the "Save" (3, Fig. 70) or "Cancel" button (4, Fig. 70) to close the display.4321DRAFTDRAFTDRAFT62014-08-21Rinsing water stations (gRinsing water stations (gThe detail view of a rinsinThe detail view of a rinsin
86 Instructions for Use V 0.5 RevC - 08/20146.4 Station features (continued)The slide racks are transported into any free unload station at the end of a program. There-fore, all unload stations must be filled with the same reagent. The samples can potentially become damaged if this is not observed.Fig. 716. Daily Instrument SetupThe load and unload stations are not taken into account when creating the bathlayout. Reagents in the load and un-load stations have to be defined and monitored by the user.Load and unload stations in the drawers:No reagents have been assigned yet to the load and unload stations in the factory condition of the instrument. To assign a reagent, run the following steps: Select the corresponding load or unload sta-tion in the bathlayout (see Fig. 20) by touching it. In the newly opened "Station details" window, press the black "Reagent name" button to open the list of available reagents (see Fig. 36, Chap. 5.8). Select the desired reagent by touching it and then hit "Apply". To apply the settings, press the "Save" button or press "Cancel" to close the display.The assigned reagent name is displayed in the bathlayout. If a reagent is no longer required in the load or unload station, the assignment to the re-spective reagent can be removed using the "Delete" and "Save" buttons in the "Station details" window.Reagent stations: An information window opens when the reagent station is touched. It displays additional relevant data regarding the station type.DRAFTDRAFTDRAFTppp2014-08-21Load and unload stations in Load and unload stations in No reagents have been assiNo reagents have been assifdl
87Leica HistoCore SPECTRA ST6. Daily Instrument Setup6.4 Station features (continued)Fig. 72Leica reagent stationFig. 73Reagent stationFig. 74Heated reagent stationReagent name/abbrevia-tionSee Chap. 5.8.1Consumption status See Chap. 6.3Remaining slides/max. slidesDisplays the number of remaining processable slides. When inserting a slide rack into the instrument, the slides contained in it are counted by the slide reading module and subtracted from the number of remaining slides. Onboard shelf life Displays the shelf life of the reagent filled into the reagent cuvette (see Chap. 5.8.1).Expiry date/batch number is applied automatically when scanning the packaging of the Leica reagent kit.Insert yes/no "Yes" indicates that the insert for special dyes and the slide rack for 5 slides is used. This station cannot be used for programs with slide racks for 30 slides (see Chap. 5.5).Exclusive Yes/No The setting "Yes" defines that the reagent is only assigned to one pro-gram. "No" allows use by multiple programs (see Chap. 5.9.6).Target temperature Indicates the user-defined temperature for a heated reagent station.Operation mode Indicates the user-defined setting for a heated reagent station (activated continuously or only when starting the program).21DRAFTDRAFTDRAFT62014-08-21tionioReagent stationReagent stationHeated reeated re
88 Instructions for Use V 0.5 RevC - 08/20146.4 Station features (continued)6. Daily Instrument SetupReagent replacement If the RMS indicates that a reagent is almost or completely consumed, a reagent change must occur. This changeover must be confirmed by pushing the "Update Reagent" (1, Fig. 72) button. When replacing the Leica reagents, first press the "Update Reagent" button and follow the instructions for scanning and filling on the screen. The "Close" (2, Fig. 72) button is used to close the display. Updating the reagent status without replacing the corresponding reagent will inevita-bly affect the staining quality negatively. NEVER press the "Update Reagent" button if the reagent has not been replaced.Each Leica reagent kit can only be scanned once! Already added Leica reagents expire before their use-by date if a bathlayout is newly created. If the newly created bathlayout is subject to a final verification by the user or is to be adapted and the Leica reagents have not yet been scanned and added, the following procedure is recommended: After creating the bathlayout, cancel the prompt to scan the Leica reagent kits. Do not carry out any fill level scan. Make up the Leica reagent kit scan and a fill level scan later.This is used to prevent the Leica reagent kit from expiring early.DRAFTDRAFTDRAFTppp2014-08-21cementcementndicates that a reagent is almost or completely consumed, a rndicates that a reagent is almost or completely consumed, a rhtbfidbhithhtbfidbhit"Udt RdR
89Leica HistoCore SPECTRA ST6. Daily Instrument Setup6.5 Prepare slide rackTwo different types of slide racks with compat-ible clips are available for use in the SPECTRA ST staining machine: Slide rack for 30 specimen slides routine stain-ings (Fig. 75). Slide rack with layered clips for 5 slides for special dyes (Fig. 76).The colored clips must be correctly attached prior to using the slide rack in the device.The rack clips must be attached corresponding to the previously defined program color (see Chap. 5.9.1).The specimen slide clips are available in 9 colors (8 program colors & white) (see Chap. 9.2).Fig. 76Fig. 75Special function of the white clip: The white clip cannot be permanently assigned to a staining program. Corresponding to a "wildcard func-tion", the white clip has to be reas-signed to a program color each time the program is started.For this purpose, a selection menu opens on the screen automatically af-ter inserting the slide rack.Each slide rack clip contains 2 RFID chips. Therefore, the slide rack clips may only be attached to the slide rack after a potential microwave step for specimen preparation.DRAFTDRAFTDRAFT62014-08-212014-slide racchips. Thereforlb tt-2108
90 Instructions for Use V 0.5 RevC - 08/2014Proceed as follows to attach or replace the slide rack clips:6.5 Prepare slide rack (continued)Detach the clip from the slide rack:  Slightly pull the clip apart so that the clip wire can be pulled from the bore in the holder. Attaching a clip to a slide rack:  Slightly pull apart the clip so that the clip wire can snap into the respective bore in the holder.  Be sure that the clip is correctly positioned in the upper position, centered above the slide rack (Fig. 77).Fig. 77Fig. 78Fig. 796. Daily Instrument SetupØØFor a stable placement for filling, fold the clip to the side as far as it goes (Fig. 78) so it can be used for addition-al protection from tipping. When inserting the slides, be abso-lutely certain that the slide label is pointing upwards and toward the user. The side of the slide with the speci-men must point toward the front side of the slide rack. The front side of the slide rack is la-beled with the Leica logo. With the clip attached, "Front" can be read when looking at the clip (Fig. 79).If the slides are not inserted correctly, the samples can become damaged in the further process sequence.DRAFTDRAFTDRAFTppp2014-08-21ows to attach or replace the slide rack clips:ows to attach or replace the slide rack clipDetach the clip from the slidDetach the clip from the slid20142014-
91Leica HistoCore SPECTRA ST6. Daily Instrument Setup6.5 Rack and preparatory work (continued)6.6.1 Start the staining process When using printable labels or manual labels on the slide rack clips and the slides, they must be checked for solvent resistance in advance. When inserting the slide into the slide rack, you have to make sure that the slides are inserted into the respective slide rack for the desired staining program. The colored slide rack clips allow secure assignment for the respective staining program. Make sure that only one slide each is put into the insert and that the slides are not jammed.6.6 The staining processThe following requirements must be met to carry out the staining process: All settings are optimized (parameters for oven, heated cuvettes, etc.). The programs required for staining have been created (see Chap. 5.9.5). The reagent stations are filled with the correct reagents (see Chap. 6.2.1). A fill level scan has been carried out (see Chap. 6.2). The slide racks intended for staining are filled and the correct clips are attached to the slide racks (see Chap. 6.5).The slide rack can be inserted using the input drawer only. Directly inserting it into any reagent or oven station by opening the instrument cover is not permitted. These slide racks cannot be recognized by the instrument and can cause collisions! Fold the slide rack clip into the upright position (see Fig. 78). If the input drawer is illuminated in green, press it and open the drawer. As shown in Fig. 80, insert the slide rack into an available input drawer position. Insert the slide rack so that both the Leica logo on the front side of the slide rack and the "Front" label on the top of the colored clip are pointing toward the user. The arrow on the top of the colored clip must point into the instrument.  Press the input drawer button again to close it again.DRAFTDRAFTDRAFT6When using printable labels or manual labels on the slide rathey must be checked for solvent resistance in advance.2014 08 21When inserting the slide into the slide rack, you have to make2014 08 21
92 Instructions for Use V 0.5 RevC - 08/2014Fig. 806. Daily Instrument Setup1 An incorrectly oriented slide rack is detected and displayed by the instrument and must be corrected by the user. The system detects if a slide rack has been inserted into the input drawer with a slide rack handle color, for which no program is specified in the bathlayout and the user is informed by a informa-tion message. The slide rack must be removed from the instrument. Corresponding to the bootable programs (see Fig. 82), attach the correct colored clip to the slide rack and re-insert it into the input drawer.Exercise caution when opening or closing the drawers! Crushing haz-ard! The drawers are motorized and open automatically when the button is pressed. Do not block the exten-sion range of the drawers. After closing the input drawer, the instru-ment detects the RFID chip in the colored clip.  The identified color of the clip and the as-signed program abbreviation are displayed in the bathlayout at the respective station (Fig. 81). 6.7.1 Start the staining process (continued)Fig. 81DRAFTDRAFTDRAFTppp2014-08-212014-e cautioclosing the drawTh d8-2108
93Leica HistoCore SPECTRA ST6. Daily Instrument SetupFig. 82For the inserted slide racks, the instrument calculates throughput-optimized start times that can deviate from the order of the inserted slide rack. Before the first program step, the instrument counts the slides used in the slide rack in the slide reading module (see 2, Fig. 4).  The determined number of slides is recorded and processed in the RMS and the consumption status of the respective reagents is updated. Afterwards, the rack is transported into an oven station or reagent station, depending on the defined first program step. The slide racks are now integrated into the staining process.6.7.1 Start the staining process (continued)6.7.2 Monitoring the staining processUsing the following menu, the user can call up or monitor details for ongoing programs: Bathlayout with station details (Fig. 81). Process status display with calculated remaining program times and step times (see Chap. 5.3). The status bar (see Chap. 5.2) with date, time and symbols that refer to messages and warnings that occurred.The last 20 messages and warnings can be called up by touching the corresponding symbol in the status bar (see 7+8, Fig. 17). This gives the user the opportunity to be-come informed about past and current situations after the instrument is absent and initi-ate the required actions, if necessary.DRAFTDRAFTDRAFT62014-08-212014-08-21
94 Instructions for Use V 0.5 RevC - 08/20146.7.3 Staining process completedThe output drawer must be opened and the slide racks removed at the latest when the warning message is received indicating that the output station is completely occupied (Fig. 84). Failure to comply with the warning message results in not being able to transport further slide racks into the output stations. Deviating step times and delays in the staining process can change the staining results.Fig. 84Fig. 83Fig. 85 The user receives a message if the output drawer is open for longer than 60 seconds (Fig. 85).The warning message requests the user to close the output drawer to prevent potential delays. When the output drawer is open, the instrument cannot place completely processed slide racks into the unload stations. Deviating step times and delays in the staining process can change the staining results.6. Daily Instrument Setup Press the button on the output drawer for closing. After a slide rack has run through the staining process, it is transported into the output drawer and placed in an available position (Fig. 83).  To remove the slide rack from the unload station, press the button on the output drawer for opening and remove the slide rack. Press the button again after removal to close the output drawer.DRAFTDRAFTDRAFTppp2014-08-21After a slide rack has run through ta slide rack has run through tit is transported into the output drit is transported into the output dran available position (ilable positFigig8383))
95Leica HistoCore SPECTRA ST6.7.4 Canceling the staining program Staining programs can only be canceled via the process status display.  To cancel a staining program, select the cor-responding slide rack in the process status display (see x, Fig. xx front) by touching it.  A list of program steps appears (Fig. 86), the current step is marked in red. The frame of the window displays the color assigned to the program, the program name and the stored abbreviation. Press the "Cancel program" button. In the following message, confirm the program termination with the "Yes" button or return to the process status display with "No".Fig. 86Fig. 87 The bathlayout is displayed after pressing the "Yes" button. The position of the slide rack is highlighted in orange in the instrument (1, Fig. 88). Open the instrument cover; remove the slide rack from the highlighted station. Close the hood again immediately. Confirm the removal of the slide rack by press-ing the marked station (1, Fig. 88).The message notes (Fig. 87) are abso-lutely necessary to observe.6. Daily Instrument SetupDRAFTDRAFTDRAFT62014-08-21Staining programs caStaining programs cathe process status disthe process status disTo cancel a staining pTo cancel a staining p
96 Instructions for Use V 0.5 RevC - 08/20146.7.5 Operation as a workstationThe SPECTRA ST can be operated as a workstation together with the SPEC-TRA CV robotic coverslipper. This al-lows an uninterrupted workflow from entering into the staining machine up to removing the completely stained and covered specimen slides. An op-tional transfer station for the SPECTRA CV is available for the SPECTRA ST (see Optional Accessories). The op-tional transfer station and connection of a SPECTRA CV to the SPECTRA ST may only be installed by a Leica-certi-fied service technician.Fig. 8916. Daily Instrument SetupRemaining staining programs are con-tinued after a program termination. Fig. 8816.7.4 Canceling the staining program (continued)When removing the slide rack, pro-ceed quickly and make sure that the hood only remains open for a short amount of time. After opening the hood, for safety reasons, all move-ments are interrupted until the hood is closed again. Deviating step times, de-lays and changed staining results can be caused each time the hood opens in the staining process.DRAFTDRAFTDRAFTppp2014-08-21When removing thceed quickly and hd l i8-21
97Leica HistoCore SPECTRA ST6. Daily Instrument SetupFig. 9012The current process status of both instruments can be shown on the screen of the SPECTRA ST. To switch between the SPECTRA ST and SPECTRA CV displays, press the "SPECTRA CV" button in the process status (5, Fig. 16). The view then changes to the SPECTRA CV status display (Fig. 89). In addition to the SPECTRA CV process sta-tus, messages are also shown on the screen that pertain to the workstation operation or SPECTRA CV. To return, press the "SPECTRA ST" (1, Fig. 89) button. The illustration of individual racks in the workstation operation displays the process sequences in both the SPECTRA ST and SPEC-TRA CV. This display is illustrated in two parts.  The upper section (1, Fig. 90) shows the pro-cess sequence in the SPECTRA ST. The lower range (2, Fig. 90) shows the process sequence in the SPECTRA CV.6.7.5 Operation as a workstation (continued)The user must adhere to the following in workstation operation! The SPECTRA ST unload stations must be filled with the same reagent (xylene or Lei-ca ST Ultra xylene substitute) as the SPECTRA CV load station(s). Each reagent added must be compatible with the mountant used. Filling the load and unload station with the same reagent is absolutely necessary in order to prevent sample losses due to drying out in the case of instrument faults.DRAFTDRAFTDRAFT6The user must adhere to the following in workstation operation!The SPECTRA ST unload stations must be filled with the sameca ST Ultra xylene substitute) as the SPECTRA CV load station(2014 08 212014 08 21
98 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and MaintenanceGeneral instructions Before each cleaning, shut down the instrument using the operating switch and then switch it off using the power switch! No liquid may come into contact with the electrical connections or spill into the inte-rior of the instrument or the housing below the transport arms! When using cleaning agents, observe the manufacturer's safety instructions and the laboratory regulations valid in the country of use. Dispose of spent reagents in accordance with the laboratory guidelines in force in your country! The following applies to all instrument surfaces: Wipe up spilled solvents (reagents) without delay! The lid surfaces only have moder-ate resistance in the event of prolonged contact with solvents! Do not use any of the following for cleaning the outside surfaces of the instrument: alcohol, detergents containing alcohol (e.g. window cleaner), abrasive cleaning pow-ders, solvents containing acetone or xylene. 7.1 Important notes about this instrument cleaning7.1.1 Exterior surfaces, varnished surfaces, instrument coverThe surfaces can be cleaned with a mild, pH-neutral, commercially available cleaning agent. After cleaning the surfaces, wipe them off with a cloth moistened with water.Varnished instrument surfaces and plastic surfaces (e.g. an instrument cover) may not be cleaned with solvents like acetone, xylene, toluene, xylene substitutes, alcohol, al-cohol mixtures and abrasives! In case of long-term exposure, the surfaces and instru-ment hood are only conditionally resistant to solvents.Clean the screen using a lint-free cloth. A suitable screen cleaner can be used in compliance with the manufacturer information.7.1.2 TFT touchscreenDRAFTDRAFTDRAFTnancenance2014 08 21eral instructionsefore each cleaning, shut down the instrument using the operatwitch it off using the power switch!2014 08 21
99Leica HistoCore SPECTRA ST7. Cleaning and Maintenance7.1.3 Interior and drain panTo clean the interior and the drain pan, remove the reagent cuvettes and water flow cuvettes. Use a mild, pH-neutral, commercially available cleaning agent to clean these areas. After cleaning the drain pan, rinse it thoroughly with water.7.1.4 Transport armsTo clean the surfaces of the transport arms, these are to be wiped off with cloth moistened with water.7.1.5 Reading module for specimen slidesCheck the recess of the specimen slide reading module for dirt and reagent residue. When us-ing specimen slides that already have damaged edges, it is possible that (1, Fig. 91) small glass shards and splinters have collected. Therefore, all dirt in this area must be carefully removed to prevent injury.1Fig. 91Ensure that no liquids spill under-neath the housing of the transport arms because there are sensitive parts here.DRAFTDRAFTDRAFT7.C2014-08-21or and the drain pan, remove the or and the drain pan, removand water flow cuvettes. Use ad water flow cuvettes. Use aommercially available cleaningommercially available cleaCheck the recess of the sCheck the recess of the smodule for dirt and reagmodule for dirt and reaging specimen slides that ing specimen slides that
100 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and Maintenance7.1.6 Input and output drawers Remove reagent cuvettes from both drawers and store them outside of the instrument. Check the inside of the drawers for reagent residue and remove where appropriate. Finally, insert the reagent cuvettes into the correct positions again. Observe the existing labeling (1, Fig. 92) for stations in the drawers.7.1.7 Dry transfer stationAfter inserting the dry transfer station, the reagents can drip down. This residue must be removed regularly.  To do so (1, Fig. 93), remove the insert of the dry transfer station by pulling upwards, check for contamination and clean if necessary. Then, re-insert the insert and make sure it snaps in correctly.7.1.8 Transfer station (optional) Check the transfer station regularly for reagent residue and clean if necessary.1Fig. 92Fig. 93Fig. 94DRAFTDRAFTDRAFTnancenance2014-cuvettes from both drawersuvettes from both drawetside of the instrument.de of the instrumentof the drawers for reagentof the drawers for reagen
101Leica HistoCore SPECTRA ST7. Cleaning and Maintenance Remove the cuvettes individually from the clip. Ensure that the clip is in the correct position (see Chap. 6.2.1) to prevent spilling the reagent.  The sealing ring (1, Fig. 95) must remain at-tached to the water flow cuvette. Dispose of reagents in accordance with the local laboratory specifications. All cuvettes can be cleaned in a dishwasher, at a maximum temperature of 65 °C, using a standard, commercially available detergent for lab dishwashers. In doing so, the clip can remain attached to the various cuvettes.7.1.9 Reagent cuvettes, rinsing water cuvettes and heated cuvettes (optional)Never clean the plastic reagent cuvettes at temperatures higher than 65 °C since it can cause the reagent cuvettes to become deformed!Fig. 95If the cleaned and filled reagent cuvettes need to be put back into the instrument, they need to be put in the correct position in accordance with the displayed arrangement of the bathlayout (see Fig. 56 in Chap. 5.9.9). To do so, switch on and initialize the instrument.  The water flow cuvettes are to be regularly checked for calcification, visible, microbiologi-cal deposits of bacteria, fungi, algae and permeability. Lime residue can be removed using a mild vinegar-based cleaning solution. Finally, rinse off the cuvettes with clear water until the cleaning agent residue has been removed.  After cleaning the water flow cuvettes and before inserting them into the instrument again, the connecting piece to the water supply system must be checked for correct positioning on the black O-ring (see 1, Fig. 95).  If an O-ring is missing or not positioned correctly, the water flow cuvettes may not be put back into position after cleaning, because otherwise there is a danger of the rinsing function being defective during the staining process.  After attaching the O-ring or correcting its position, the water flow cuvettes can be put back into position.1DRAFTDRAFT7.C2014-08-21uvettes individually from the uvettes individually fromhat the clip is in the correct at the clip is in the correct ChapChap621621) to prevent spilling) to prevent sp08-21
102 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and Maintenance The rack is to be checked regularly for staining residue and other possible contamination. The stained clip must be removed from the rack for cleaning.  To remove staining reside from the rack, immerse it in a bath of lukewarm water and a mild, pH-neutral lab cleaner and let the cleaner take effect. When doing so, carefully observe the additional manufacturer information regarding cleaning agents and the recommended application area.  Then, strong staining contamination can be removed using a brush. Now, take your time to thoroughly rinse off the racks with fresh water until no more staining and cleaning agent residue remains. If residue from the mountant remains on the racks, these can be placed in a bath of solvent. The rack and clip may not remain in the solvent for a long time frame (e.g. several hours or overnight), because this can lead to deformities! It is essential to ensure that the solvent being used is compatible with the mountant. Xylene or toluene-based mountants can be removed using a xylene bath. Xylene sub-stitute-based mountants are removed using a bath containing a corresponding xylene substitute.The maximum exposure time in a solvent bath is 1-2 hours. The solvent can be washed off with alcohol. Completely rinse the rack racks with water, then dry. If an additional drying oven is used, a temperature of 70 °C may not be exceeded.7.1.10 Rack and clipDRAFTDRAFTDRAFTnancenance2014-08-21to be checked regularly for staining residue and other possto be checked regularly for staining residue and other poss clip must be removed from the rack for cleaning.clip must be removed from the rack for cleaning. staining reside from the rack immerse it in a bath of lukewarstaining reside from the rack immerse it in a bath of lukewar
103Leica HistoCore SPECTRA ST7. Cleaning and Maintenance7.1.11 Water drainImage of procedure!Fig. 96Image of sieve!Fig. 97The draining system within the in-strument must be regularly cleaned and checked for correct flow. If this measure is not completed, the water draining system must become clogged, which could lead to interruptions or malfunctions in the staining process. To clean the water draining system, remove the 4 rear water flow cuvettes and all sur-rounding reagent cuvettes.  The remaining cuvettes must be covered.  Remove the drainage sieve and clean if neces-sary Fig. 97. Place one to two cleaning tablets with active oxygen (e.g. a denture cleanser) into the drain-age and dissolve in water to remove various residue (reagents, bacteria, fungi, algae). Then, clean the entire curved drainage inside the instrument with a long, flexible brush Fig. 96. Check the flow by flushing thoroughly with water. Insert the drainage sieve again, and put the cu-vettes back in their original, defined positions.DRAFTDRAFTDRAFT7.C2014-08-2108-21aining system within thet must be regularly cleaned ecked for correct flow If2014-
104 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and Maintenance7.1.12 Water drain hoseThe water drain hose must be checked once a year by a service technician authorized by Leica.The integrated water intake filter included with the instrument protects instrument's internal water circuit components from damage due to sediments and mineral deposits. The water intake filter should therefore be checked regularly and, when discolorations are visible due to deposits, washed out or replaced if necessary.  To do so, shut off the water inlet. Unscrew the upper filter housing by rotating the filter housing. Pull out the filter insert and wash it out or insert a new filter insert if necessary.  Re-attach and screw the filter housing. Reopen the water inlet.Filter housingFilter cartridgeOrder No.: 14 0512 49332Fig. 987.1.13 Water intake filter – changing the filter cartridgeDRAFTDRAFTDRAFTnancenance2014-08-21must be must bechecked once a year by a service technician authhecked once a year by a service technician auth
105Leica HistoCore SPECTRA ST7. Cleaning and MaintenanceThe active carbon filters installed in the instru-ment helps reduce the amount of reagent vapors in the exhaust air. The life cycle of the filter can fluctuate strongly depending on intensity of use and the reagent configuration of the instrument. Therefore, replace the active carbon filter regu-larly (every 2-3 months) and dispose of it proper-ly in accordance with the laboratory regulations applicable in the country of use. The filter unit consists of two individual filter elements (Fig. 99), which are accessible to the user on the front of the instrument.  They can be accessed without tools and re-moved by pulling on the pull tabs.  Insert the new filter elements in an inverted direction and in the same way so that the pull tabs can also be seen and reached after push-ing in completely and the printed-on arrow points upwards. Both active carbon filters must be pushed in until you feel them make contact with the rear panel of the instrument. Fig. 997.1.14 Replacing the active carbon filterIf inserted incorrectly, the active car-bon filters can extend into the range of movement of the two transport arms, impeding or interrupting the staining process.DRAFTDRAFTDRAFT7.C2014-08-21n filters installed in the instrun filters installed in the in-e the amount of reagent vaporsthe amount of reagent vaporsThe life cycle of the filter canThe life cycle of the filte08-21
106 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and MaintenanceBeware of hot surfaces: After using the oven in the staining process, first switch the instrument off before cleaning and wait for it to cool off. Only hold the oven inserts at the described posi-tions.7.1.15 Cleaning the ovensFig. 100112233Regularly clean the sheet metal inserts for catch-ing paraffin residue in the oven for dirt. Fold the moving oven cover up and to the left, (1, Fig. 100) then pull it towards the front of the instrument. Grasp both connected oven chambers in the center (2, Fig. 100+101) and pull them upwards.Fig. 101The interior of the oven must not be cleaned using solvents, as there is a risk that solvent residues will get into the oven and evaporate in the oven when the process begins.For safe transport, after pulling out the two oven chambers that are still con-nected, stabilize them on the bottom by grasping them with your flat hand. Disconnect the two oven chambers by pulling them up in opposite directions. You can then pull out the insert for catching paraffin residue from the respective oven chamber (3, Fig. 101). Check the sheet metal inserts for paraffin resi-due and dirt. To melt the paraffin, the inserts can be placed in an external laboratory oven.  After heating, wipe off the paraffin residue with a lint-free cloth. Check the ventilation flaps in the oven cham-bers for proper function. If they are visibly dirty, carefully clean them with a lint-free cloth. Push the sheet metal insert into the respective oven chamber, facing the right way. Put both oven chambers back together and insert them into the instrument.DRAFTDRAFTDRAFTnancenance2014 08 21of hot surfaces: After using the oven in the staining process, first sefore cleaning and wait for it to cool off. Only hold the oven inserts at s2014 08 21
107Leica HistoCore SPECTRA ST7. Cleaning and MaintenanceThe air filter of the oven should be checked and cleaned regularly.  To do so, remove the filter insert (1, Fig. 102) and shake it out. After checking and cleaning, re-insert into the oven in the same way.The installation is carried out in re-verse order.7.1.16 Oven air filterFig. 102DRAFTDRAFTDRAFT7.C2014-08-21e oven should be checked and e oven should be checkedove the filter insert (ove the filter inser1Figg102)08-21
108 Instructions for Use V 0.5 RevC - 08/20147. Cleaning and Maintenance7.2 Recommended maintenance and cleaning intervalsTo ensure trouble-free operation of the instrument over a long period of time, the following is strongly recommended: You must carry out the maintenance and cleaning tasks listed below. Have the instrument checked at least once a year by a qualified service technician autho-rized by Leica. At the end of the warranty period, enter into a service contract. For more information, contact the relevant customer service organization.Daily cleaning and maintenanceIf sensitive instrument parts and areas get very dirty or if reagents are spilled, they must be cleaned immediately, as otherwise a reliable workflow is not guaranteed.Task Refer also to Checking and filling/refilling the reagent cuvettes. Chap. 6.2.1 Covering the reagent cuvettes and, if necessary, storing them with covers in the refrigerator. Checking the rack and clips for paraffin or dye residue and broken glass. Chap. 7.1.10 Check the slide reader module for reagent residue and clean it if necessary.Chap. 7.1.5 Check the housing in the area of the input and output drawers for solvent residue and clean it if necessary.Chap. 7.1.6 Check the transfer station (optional workstation) (Fig.) for solvent resi-dues and clean if necessary.Chap. 7.1.8 Clean the insert of the dry transfer station and clean if necessary. Chap. 7.1.7DRAFTDRAFTDRAFTnancenance2014-08-21ble-free operation of the instrument over a long period of tble-free operation of the instrument over a long period of tmended:mendedarry out the maintenance and cleaning tasks listed belowarry out the maintenance and cleaning tasks listed belo
109Leica HistoCore SPECTRA ST7. Cleaning and MaintenanceTask Refer also to Checking/cleaning the water flow cuvettes for bacterial contamination and checking the sealing rings to make sure that they are presentChap. 7.1.9  Cleaning the reagent cuvettes Chap. 6.2.1 Checking/cleaning the heated reagent cuvettes Chap. 7.1.9 Cleaning the racks and clips. Chap. 7.1.10 Check the water drain and sieve within the instrument for proper func-tion and clean it if necessary.Chap. 7.1.11 Checking transport arms for dirt and clean if necessary. Chap. 7.1.4Weekly cleaning and maintenanceTask Refer also to Checking the water intake filter and changing it if necessary. Chap. 7.1.13  Checking and cleaning the air filter of the drying oven. Chap. 7.1.16 Cleaning the drip tray. Chap. 7.1.3 Checking the drying oven insert and catch tray for paraffin residue and cleaning it.Chap. 7.1.15Monthly maintenance and cleaningCleaning and maintenance as necessaryTask Refer also to Clean the screen using a lint-free cloth. A screen cleaner can be used according to manufacturer instructions.Chap. 7.1.2  Cleaning outer/painted surfaces Chap. 7.1.1 Instrument cover Chap. 7.1.1DRAFTDRAFTDRAFT7.C2014 08 212014 08 212014-08-21he screen using a lint-free cloth. A screen cleaner can be us
110 Instructions for Use V 0.5 RevC - 08/2014Task Refer also to Checking and maintenance of the instrument by a service technician authorized by Leica. Task Refer also to Changing the active carbon filter. Chap. 7.1.14 Quarterly cleaning and maintenanceAnnual maintenance and cleaning7. Cleaning and MaintenanceTask Refer also to Replace the water intake filter. Chap. 7.1.13 Cleaning and maintenance every six monthsDRAFTDRAFTDRAFTnancenance2014-08-212014-08-21he active carbon filter.
111Leica HistoCore SPECTRA ST8. Malfunctions and TroubleshootingError/problem Cause TroubleshootingRising water level in the drain pan with alarm.Water drain partially or com-pletely blockedChecking and maintaining the water drain hose. For this purpose, contact the responsible Leica service.Water drainage system in-side the instrument and/or the drainage sieve partially or completely blocked.Checking and maintaining the water drain system in the instrument. Observe the cleaning instructions in Chap. 7.1.11.Observe regular maintenance in-tervals.If the blockage remains, the water inflow to the water flow cuvettes is stopped and the staining process is interrupted. Therefore, the speci-mens have to be removed from the instrument and brought to a safe position or temporary storage (see warning message in Chap. 8.2). Decreased flushing during the staining cycles with possibly inconsistent staining results.Water inlet in water flow cu-vettes attenuated/blocked.Possible causes: Water flow cuvettes fit in-correctly (note O-ring). Calcification of the water flow cuvette.Monitoring and maintaining the water flow cuvettes.Observe the cleaning instructions in Chap. 7.1.9.Observe regular maintenance in-tervals.Water flow cuvettes do not drain automatically during breaks in operation of the in-strument. Standing water can be a source for microbiologi-cal contamination in the water flow cuvette and the samples.The additional water drain hole at the base of the water flow cuvettes is blocked by calcifi-cation/dirt.Monitoring and maintaining the water flow cuvettes.Observe the cleaning instructions in Chap. 7.1.9.Observe regular maintenance in-tervals.8.1 Fault remedies for instrument malfunctionsDRAFTDRAFTDRAFT8.. MalfuncMalfu2014-08-21CauseCauTroubleshootTroubleshootl in the drain l in the drain Water drain partially or comater drain partially or com- Checking andhecking and
112 Instructions for Use V 0.5 RevC - 08/20148. Malfunctions and TroubleshootingError/problem Cause TroubleshootingInsufficient flushing during the staining processes may yield inconsistent staining results.Water pressure too low in the intake drainage system of the lab or fluctuations at different times of the day The specified minimum require-ments for water pressure (see Chap. 3.2) must be fulfilled (even for possible deviations during the daytime).Plastic cuvettes are deformed. Use of reagents that are not permitted (ex. phenol in Ziehl-Neelson dye or Gram dye, etc.).Incorrectly applied cleaning procedure.Monitoring the used reagents using the list of permitted reagents (see Appendix 1).Observe the cleaning instructions in Chap. 7.1.9.Inconsistent staining results The tolerance of the program step for staining reagents is not correctly defined. Inspecting the staining protocols and reagents.Most short program steps demand exact compliance with the staining step. The tolerance of the reagent must be set to 0 %.Varying staining results The process classes (paraffin removal, stainers, differentia-tion, etc.) for reagents were not correctly assigned. This means that the bathlayout might not have been optimally created.Inspecting and correcting the as-signed reagent classes based on Chap. 5.8.1Reagents that are only to be used by one program are used by other programs. The reagent is dirty because it was not pro-grammed as "Exclusive".Inspecting and correcting the pro-gramming of respective reagents.8.1 Fault remedies for instrument malfunctions (continued)DRAFTDRAFTDRAFTubleshootingubleshooting2014-08-21CauseCauseTroubleshootingTroubleshootingduring the during the Water pressure too low in the Water pressure too low in the The specified The specified m
113Leica HistoCore SPECTRA ST8. Malfunctions and TroubleshootingError/problem Cause TroubleshootingAfter drying, tissue does not adhere well enough to the slide, and floats away during the staining process.For customer-defined program protocols, the selected firing time and oven temperature (or both) are too low.Inspecting and correcting infor-mation about firing time and oven temperature for customer-defined protocols.The staining processes are complete, but repeated or additional programming (su-pervisor mode) cannot be completed.Programming can only be com-pleted when the instrument is in sleep mode; in other words, no racks may be in the process; this also includes the positions of the output drawer.Remove racks from the output draw-er, then carry out programming.Initialization of the instrument cannot be completed.Arms are blocked. Check that the active carbon filter is in the correct position.8.1 Fault remedies for instrument malfunctions (continued)DRAFTDRAFTDRAFT8.. MalfuncMalfu2014-08-21CauseCauTroubleshootTroubleshootue does not ue does not For customer-defined programr customer-defined programInspecting aspecting a
114 Instructions for Use V 0.5 RevC - 08/20148. Malfunctions and Troubleshooting In case of a temporary power failure (under 5 seconds), the instrument will continue to be operated without interruption via an internal output buffering. However, all staining programs are canceled if there is a longer-term power failure for more than 5 seconds. A rack located in the transfer is attached to the closest possible secure position between the reagent stations. This is done to prevent accidental lowering into a reagent not compatible with the program.  Afterwards, the rack must be removed from the transfer arm (Fig. 104). This occurrence is saved in the results protocol (see Chap. 5.7.9). All racks within the process must be removed from the instrument by hand. Also be sure to check the following positions on the rack and remove if necessary: - Reader module for specimen slides (see 2, Fig. 4) - Oven (see 10, Fig. 4) - Transfer station for SPECTRA CV (see 6, Fig. 4) Make sure that the specimens are stored outside of the instrument in a suitable reagent and that the steps of the current staining protocol are continued to the end of the protocol manually. The user shall be responsible for further processing of the samples. After the power supply is restored, the instrument can be restarted and loaded with new specimens. Image, removal of rack from the transfer arm during power failureFig. 1048.2 Power failure scenarioDRAFTDRAFTDRAFTubleshootingubleshooting2014-08-21a temporary power failure (under 5 temporary power failure (underseconds), the instrumenseconds), the instrumenithout interruption via an internal output buffering.thout interruption via an internal output buffering.ll staining programs are canceled if there is a longer term poll staining programs are canceled if there is a longer term po
115Leica HistoCore SPECTRA ST8. Malfunctions and Troubleshooting8.3 Replace main fusesThe instrument should be switched off using the power switch and disconnected from the power supply in the case of a instrument failure. The main fuses can then be inspected. To do so, open the hood and unscrew the two fuse holders on the top of the right cover (1, Fig. 103) with a flat-head screwdriver and check for damage. Fig. 1031A suitable flat-head screwdriver must be used to prevent damage to the fuse holder. Beware of defective fuses! Potential risk of injury due to broken glass! If the fuse is defective, remove it from the fuse holder and replace it with a new fuse. Installation occurs in the reverse sequence of operations.Only fuses with a T16 A H 250 V AC fuse rating can be used.DRAFTDRAFTDRAFT8.. MalfuncMalfu2014-08-21The instrument should beThe instrument should bepower switch and disconpower switch and disconsupply in the case of asupply in the case of a2014-
116 Instructions for Use V 0.5 RevC - 08/20149. Instrument Components and SpecificationsFig. 1059.1 Optional instrument componentsThe SPECTRA ST slide stainer can be equipped with the following optional modules. A subse-quent equipment configuration with one or more of the options listed below is possible. Note that retrofitting also incurs a fee for a service call that can result in additional costs along with the option costs.Using the slide reader module, specimen slides with printed barcodes can be read out and the information can be sent to a LIS network system connected to the instrument.Note that specimen slide labels can be read us-ing this module only if they contain the following properties:Barcode types:  1D barcode: Code 128, up to 8 characters 1D barcode: CODABAR, up to 8 characters  2D barcode: Datamatrix, 17 mil. resolution, up to 30 characters 2D barcode: QR code, min. 21x21, max. 30x30 elements The print quality of the specimen slide label must at least conform to the quality level 2 (C) in ac-cordance with ISO 15416 and EN797.Order No. 14 0512 47193Reader module for specimen slidesThe component(s) must only be subsequently installed by Leica certified service techni-cians. This can result in additional costs.DRAFTDRAFTts and Specificationsts and Specificationp2014-08-21ST slide stainer can be equipped with the following optionaST slide stainer can be equipped with the following optionant configuration with one or more of the options listed belont configuration with one or more of the options listed beloalso incurs a fee for a service call that can result in additioalso incurs a fee for a service call that can result in additio
117Leica HistoCore SPECTRA ST9. Instrument Components and Specifications9.1 Optional instrument components (continued)Fig. 106Fig. 107Module with four individually heated reagent cuvettes, 380 mlHeated reagent cuvettes can individually heat up to 4 reagents used for special dyes. The module includes 4 heatable reagent cuvettes that replace 4 unheated plastic reagent cuvettes. The list of usable reagents (see Appendix 1) must be observed.Order No. 14 0512 47509Leica SPECTRA CV: for use in the SPECTRA ST, transferring samples to a connected robotic coverslipperWhen integrating a SPECTRA CV robotic cover-slipper, this module is used as a workstation. It transfers the specimen slide automatically from the staining machine into the robotic coverslipper.Order No.: 14 0512 47395Heated reagent cuvettesTransfer module for racksDRAFTDRAFTDRAFT9.9. Instrument CompInstrument Com2014-08-212014M d l ith f i di iM d l ith f i di icuvettescuvettes
118 Instructions for Use V 0.5 RevC - 08/20149.2 Optional AccessoriesSpecimen slide*Designation Order No.Outlet hose, length: 2 m 14 0475 35747Supply hose for rinsing water 14 0474 32325Water connection kit with filterSupply hose 3, length: 1.5 m extensionY pieceDouble nipple G3/4 G3/8Water filter housingFilter cartridgeBushing G3/414 0512 4932414 0512 4933414 3000 0035114 3000 0035014 0512 4933114 0512 4933214 3000 00360Exhaust hose, length 2 m 14 0475 35762Active carbon filter 14 0512 47131Reagent cuvette, assembly, including reagent cuvette cover 14 0512 47086Water flow cuvette assembly 14 0512 47087Used for special dyes (only for racks designed for up to 5 specimen slides) 14 0512 49261Rack for 30 specimen slides* (3 pcs. per package) 14 0512 52473Rack 5 specimen slides* (3 pcs. per package) 14 0512 52475Clip for rack 30 specimen slides* (yellow, 3 pcs. per package) 14 0512 52476Clip for rack 30 specimen slides* (light blue, 3 pcs. per package) 14 0512 52477Clip for rack 30 specimen slides* (dark blue, 3 pcs. per package) 14 0512 52478Clip for rack 30 specimen slides* (pink, 3 pcs. per package) 14 0512 52479Clip for rack 30 specimen slides* (red, 3 pcs. per package) 14 0512 52480Clip for rack 30 specimen slides* (light green, 3 pcs. per package) 14 0512 52481Clip for rack 30 specimen slides* (black, 3 pcs. per package) 14 0512 52482Clip for rack 30 specimen slides* (gray, 3 pcs. per package) 14 0512 52483Clip for rack 30 specimen slides* (white, 3 pcs. per package) 14 0512 52484Clip for rack 5 specimen slides* (yellow, 3 pcs. per package) 14 0512 52494DRAFTDRAFTDRAFT2014-08-212014-08-212014-08-212014-08-212m
119Leica HistoCore SPECTRA STDesignation Order No.Clip for rack 5 specimen slides* (light blue, 3 pcs. per package) 14 0512 52495Clip for rack 5 specimen slides* (dark blue, 3 pcs. per package) 14 0512 52496Clip for rack 5 specimen slides* (pink, 3 pcs. per package) 14 0512 52497Clip for rack 5 specimen slides* (red, 3 pcs. per package) 14 0512 52498Clip for rack 5 specimen slides* (light green, 3 pcs. per package) 14 0512 52499Clip for rack 5 specimen slides* (black, 3 pcs. per package) 14 0512 52500Clip for rack 5 specimen slides* (gray, 3 pcs. per package) 14 0512 52501Clip for rack 5 specimen slides* (white, 3 pcs. per package) 14 0512 52502Specimen slide*DRAFTDRAFTDRAFT2014-08-212014-08-212014-08-212014-08-21ecimen slides* (light blue, 3 pcs. per packag
120 Instructions for Use V 0.5 RevC - 08/2014Fig. 108Fig. 109Fig. 1110Outlet hose,Length: 2 mOrder No. 14 0475 35747Supply hose for rinsing water,Length: 2.50 m assembly with 3/4" connection for water tap, incl. replacement sealOrder No. 14 0474 32325Water connection kit with filterOrder No. 14 0512 49324Supply hose 3,Length: 1.5 m extension 14 0512 49334Y piece 14 3000 003512x G3/4 G3/8 double nipple 14 3000 00350Walter filter housing 14 0512 49331POROPLAST filter cartridge 14 0512 49332Bushing G3/4 14 3000 003609. Instrument Components and SpecificationsDRAFTDRAFTDRAFTts and Specificationsts and Specificationp-08-21-Length: 2Length: 2mmOrder No.Order No
121Leica HistoCore SPECTRA STFig. 111Fig. 112Fig. 113Exhaust hose,Length 2 m, assembly,including adapter for fume hoodOrder No. 14 0475 35762Active carbon filterOrder No. 14 0512 47131Reagent cuvetteassembly, incl. reagent cuvette coverOrder No. 14 0512 470869. Instrument Components and SpecificationsDRAFTDRAFTDRAFT9.9. Instrument CompInstrument Com2014-08-21-Length 2Length 2m, assembly,sembincluding adapter for fumncluding adapter for fumOd NOd N
122 Instructions for Use V 0.5 RevC - 08/2014Fig. 114Fig. 115Fig. 116Water flow cuvette assembly,Order No. 14 0512 47087Used for special dyes(only for racks designed for up to 5 specimen slides),Ø 10 mm, length: 2.5 mOrder No. 14 0512 49261Rack30 specimen slides* (3 pcs. per package)Order No. 14 0512 524739. Instrument Components and SpecificationsDRAFTDRAFTDRAFTts and Specificationsts and Specificationp2014-08-21-Order No.Order No.
123Leica HistoCore SPECTRA STFig. 117Fig. 118Fig. 119Rack5 specimen slides* (3 pcs. per package)Order No. 14 0512 52475Clip for rack,30 specimen slides*, (3 pcs. per package)yellow 14 0512 52476light blue 14 0512 52477dark blue 14 0512 52478pink 14 0512 52479red 14 0512 52480light green 14 0512 52481black 14 0512 52482gray 14 0512 52483white 14 0512 52484Clip for rack,5 specimen slides*, (3 pcs. per package)yellow 14 0512 52494light blue 14 0512 52495dark blue 14 0512 52496pink 14 0512 52497red 14 0512 52498light green 14 0512 52499black 14 0512 52500gray 14 0512 52501white 14 0512 52502Set of slide racks for 5 slides, pack of 39. Instrument Components and SpecificationsDRAFTDRAFTDRAFT9.9. Instrument CompInstrument Com2014-08-21-5 specimen slides (3 pcs5 specimen slides (3 pcsOrder No.Order No
124 Instructions for Use V 0.5 RevC - 08/201410. Garantie und ServiceWarranty Leica Biosystems Nussloch GmbH guarantees that the contractual product delivered has been sub-jected to a comprehensive quality control procedure based on the Leica in-house testing standards, and that the product is faultless and complies with all technical specifications and/or agreed char-acteristics warranted. The scope of the warranty is based on the content of the concluded agreement. The warranty terms of your Leica sales organization or the organization from which you have purchased the contractual product shall apply exclusively. Service information If you are in need of technical customer support or spare parts, please contact your Leica represen-tative or the Leica dealer where you purchased the instrument.Please provide the following information:  Model name and serial number of the instrument.  Location of the instrument and name of a contact person.  Reason for the service call.  The delivery date of the instrument. DRAFTDRAFTDRAFT2014-08-21ssloch GmbH guarantees that the contractual product delivssloch GmbH guarantees that the contractual product delivnsive quality control procedure based on the Leica in-housnsive quality control procedure based on the Leica in-housis faultless and complies with all technical specifications ais faultless and complies with all technical specifications add
125Leica HistoCore SPECTRA ST11. Decommissioning and DisposalThe instrument or parts of the instrument must be disposed of according to existing ap-plicable, local regulations. All objects contaminated with spilled reagents must be dis-infected immediately with a suitable disinfectant to prevent spreading to other areas of the lab or to lab personnel.Please comply with the Cleaning chapter for notes on cleaning the SPECTRA ST staining ma-chine.The instrument can be contaminated when using biohazardous specimens. Thorough disin-fecting is required before re-commissioning or disposal (e.g. multiple cleaning steps, disinfec-tion or sterilization). Dispose of the instrument in compliance with the applicable laboratory specifications.Contact your Leica representative for more information.Instrument components such as the computer, monitor, etc. that are la-beled with the crossed-out dust bin are affected by the European Directive 2002/96/EC for Waste Electrical and Electronic Equipment (WEEE) of the European Parliament and the Council of January 27, 2003.These objects must be disposed of via the collection points in accordance with the local regulations. More information on disposal of the instrument can be obtained from your local disposal company or your local Leica sup-port staff.DRAFTDRAFTDRAFT11.11.Decoehe instrument or parts of the instrument must be disposed of acplicable, local regulations. All objects contaminated with spillefected immediately with a suitable disinfectant to prevent sprehe lab or to lab personnel.
126 Instructions for Use V 0.5 RevC - 08/201412. Decontamination Certificate (master)Dear Customer,Any product which is to be returned to Leica Biosystems or serviced on site, must be cleaned and decontami-natedin the appropriate manner. Since it is not possible to decontaminate against diseases caused by prions such as CJD, BSE or CWD, instruments that have come into contact with prion-contaminated specimens cannot be returned to Leica Biosystems for repairs. Prion-contaminated instruments will only be repaired after the service technician has been made aware of the potential risks, informed about the applicable directives and procedures for the respective institution, and provided with personal protective equipment. Please complete this certificate carefully and place a copy with the instrument, attach it to the outside of the transport case or hand it directly to the service engineer. If packages are returned, they will not be opened or have maintenance measures begun until the Company or service technician has received confirmation of decontamination. Should returned goods be considered a hazard by the Company, they will be returned immediately to the customer at his/her expense.AThis equipment has not been in contact with unfixed biological samples.YesBBInnere o. äußere Bereiche des Gerätes waren folg. gefährl. Substanzen ausgesetzt:1Yes NoYes NoAdditional information Blood, bodily fluids, pathological samplesOther biohazardsChem. Stoffe/gesundheitsgefähr. SubstanzenOther hazards2This equipment has been cleaned and decontaminated:Additional information If yes, give details of the method:If no*, please indicate why not:* Such equipment must not be returned without the written agreement of Leica Biosystems.Designation Name/Model Fabr. No. KAT No. QuantityCheck box A if applicable. Otherwise please complete all parts of B, provid-ing further information as requested or appropriate.DRAFTAFTDRAFTificate (master)ificate (master)()2014-08-21o be returned to Leica Biosystems or serviced on site, must be clebe returned to Leica Biosystems or serviced on site, must be clener. Since it is not possible to decontaminate against diseases cer. Since it is not possible to decontaminate against diseases cinstruments that have come into contact with prion-contaminatinstruments that have come into contact with prion-contaminat
127Leica HistoCore SPECTRA STImportant - to avoid refusal of shipment: Place one copy in the unit prior to packaging or hand it over to the service engineer. Customer as-sumes all responsibility for the immediate return shipment of articles sent to Leica without proper decontamination documentation. If you have any further questions, please call your local Leica branch office.Leica Internal Use: If applicable, note corresponding Job and RAN/RGA numbers: Job Sheet No.: ____________________SU Return Goods Authorization: ____________________ BU Return Authorization Number: ____________________Leica Biosystems Nussloch GmbHHeidelberger Str. 17-1969226 Nussloch, GermanyPhone: +49 (0) 6224 143 0Fax: +49 (0) 6224 143 268Web: www.LeicaBiosystems.comSignature/Date Name Position E-mailInstitute DepartmentAddress Phone Fax3Yes No The equipment has been prepared to ensure safe handling/transportation.Whenever possible, please use the original packaging.12. Decontamination Certificate (master)BDRAFTDRAFTDRAFT12.12. DecontamiDeconta2014-08-21he equipment has been prepared to ensure safe handling/trhe equipment has been prepared to ensure safe handling/trWhenever possible, please use the original packaging.henever possible, please use the original packaging
128 Instructions for Use V 0.5 RevC - 08/2014Appendix 1 Using non-listed reagents (e.g. acetone or solutions containing phenol) or reagents and acids in higher concentration than described can cause specimens to be de-stroyed, operators to be injured or the instrument to be damaged. Use the instrument in this way at your own risk. Leica Biosystems or affiliated sales and service organi-zations shall not assume any warranty claims or liability. Flammable reagents and solvents must not be heated for fire and explosion protec-tion reasons. Keep away all ignition sources when handling flammable solvents and reagents.Staining method or reagent group Reagent name NotesH&E kit Leica Infinity ST HemalastST HematoxylinST DifferentiatorST BluingST EosinLeica SelecTech 560 Hematoxylin560MX HematoxylinDefine MX-aqBlue Buffer-8Y515 Alcoholic EosinY515LT Alcoholic Eosin515 Eosin TrichromeEosin PhloxineA1 Compatible reagentsAll Leica reagents for preinstalled Leica programs are tested with the instrument for staining quality and compatibility of materials. DRAFTDRAFTDRAFT2014 08 21g non-listed reagents (e.g. acetone or solutions containing nd acids in higher concentration than described can cause spro ed operators to be inj red or the instr ment to be damaged2014 08 21
129Leica HistoCore SPECTRA STAppendix 1Staining method or reagent group Reagent name NotesOther H&E re-agentsLeica Gill II HematoxylinGill III HematoxylinHarris HematoxylinMayer's HemalaunLeica Alcoholic EosinAqueous Eosin (1 %)Leica Scott's Tap Water SolutionLeica Acid Alcohol 0.5 %Leica Acid Alcohol 1.0 %Customer/User-definedHydrochloric Acid 2 %PAS Leica Periodic Acid 0.5 %Customer/User-definedPeriodic Acid (up to 10 %)Leica Schiff's ReagentDiastase-PAS Leica Diastase-Solution (37 °C)  Use in heated reagent cuvette: 37 °CA1 Compatible reagents (continued)DRAFTDRAFTDRAFT2014-08-21220144082212201424-08-24212reagent groupReagent nameNoteee--LeicaLeicaGill II HematoxylinGill II Hematoxylin
130 Instructions for Use V 0.5 RevC - 08/2014Appendix 1A1 Compatible reagents (continued)Staining method or reagent group Reagent name NotesAlcian Blue-PAS Leica Alcian Blue-SolutionAlcian Blue LeicaAlcian Blue and other Staining MethodsLeica Nuclear fast RedGomori Trichrome Blue and Green Collagen StainingLeica Weigert Hematoxylin (A+B Solution)Gomori Trichrome Blue Stain1 % Acetic AcidLight GreenPerl's Iron StainingLeica Potassium-Ferrocyanide Solution Must not come into con-tact with metal ions Only for use with coated 5 series rack clipsHydrochloride Acid SolutionGiemsa Leica Methanol Solution AStain 1 Solution BStain 2 Solution CBuffer Solution DCongo Red Amyloid StainLeica Congo Red SolutionLeica 1 % Potassium Hydroxide SolutionCustomer/User-definedSaturated Lithium Carbonate SolutionDRAFTDRAFTDRAFT2014-08-2120140822122014-08-2212agent grouReagent naNotesLeicaLeicaAlcian Blue-Solutioncian Blue-Solution
131Leica HistoCore SPECTRA STAppendix 1A1 Compatible reagents (continued)Staining method or reagent group Reagent name NotesAlcian Yellow for Helicobacter PyloriLeica Alcian Yellow-Solution (0.25 %Alcian Yellow)5 % Periodic Acid5 % Sodium Metabisulfite6.8 pH Sorensen BufferToluidin Blue SolutionElastic Stain/Ver-hoeff's van GiesonLeica 5 % Alcoholic Hematoxylin10 % Ferric ChlorideLugol's Iodin Solution2 % Ferric ChlorideVerhoeff's Staining SolutionVan Gieson's StainDRAFTDRAFTDRAFT2014-08-21220144082212201424-08-24212reagent groupReagent nameNoteLeicaLeicaAlcian Yellow-Solution Alcian Yellow-Solution
132 Instructions for Use V 0.5 RevC - 08/2014Appendix 1A1 Compatible reagents (continued)Staining method or reagent group Reagent name NotesGomori Methena-mine Silver StainLeica Modified Chromic Acid (up to 5 %) Use in heated reagent cuvette: 55 °C Must not come into con-tact with metal ions Only for use with coated 5 series rack clipsMethenamine Borax0.5 % Silver Nitrate1 % Sodium Bisulfate1 % Gold Chloride2 % Sodium ThiosulfateLight GreenPapanicolaou(PAP)Leica EA-50Leica Orange G-6Leica EA-65 (Secondary Counter Stain)DRAFTDRAFT2014-08-212014082212014-08-2212agent grouReagent naNotesLeicaLeicaModified Chromic Acid (upodified Chromic Acid (up Use e
133Leica HistoCore SPECTRA STAppendix 1A1 Compatible reagents (continued)Staining method or reagent group Reagent name NotesSchmorl's ReductionSchmorl's Solution  Only for use with coated 5 series rack clips(Müller) Colloidal IronColloidal Iron Solution  Only for use with coated 5 series rack clipsFerrocyanide-Hydrochloric Acid SolutionOther reagents Customer/User-definedAnilin BlueCustomer/User-definedMethylene BlueCustomer/User-definedFast GreenCustomer/User-definedCarminCustomer/User-definedSouthgate or Mayer's Mici-carmineCustomer/User-definedNeutral RedCustomer/User-definedSafraninDRAFTDRAFTDRAFT2014-08-21220144082212201424-08-24212reagent groupReagent nameNoteSchmorl's SolutionSchmorl's SolutionOO
134 Instructions for Use V 0.5 RevC - 08/2014Appendix 1A1 Compatible reagents (continued)Staining method or reagent group Reagent name NotesSolvent Leica/Customer Xylene, TolueneLeica Leica ST Ultra Xylene Substitute based on Alipahtic HydrocarbonsLeica Leica Clearene Limonene based Xylene SubstituteMerck Merck Neo-Clear Xylene Substitute based on Alipahtic HydrocarbonsCarl Roth Roti®-Histol Limonene based Xylene SubstituteRichard-Allen Sci./Thermo Sci.Clear-Rite 3 Xylene Substitute based on Alipahtic HydrocarbonsRichard-Allen Sci./Thermo Sci.Citrus Clearing Solvent Limonene based Xylene SubstituteAlcohol Leica/Customer 2-Propanol (Isopropanol)Leica/Customer EthanolMethanolRichard-Allen Sci./Thermo Sci.Dehydrant Ethyl Alcohol, Methyl Al-coholRichard-Allen Sci./Thermo Sci.Flex Isopropyl, Alcohol, Methyl AlcoholUsual Acids (Max. Concentration)Customer/User-definedAcetic Acid (up to 15 %)Hydrochloric Acid (up to 5 %)Picric Acid (up to 3 %)DRAFTDRAFTDRAFT2014-08-2120140822122014-08-2212agent grouReagent naNotesLeica/CustomerLeica/CustomXylene, Tolueneene, Toluene
DRAFT2014-08-21
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